TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
Device Facts
| Record ID | K141289 |
|---|---|
| Device Name | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS |
| Applicant | Teco Diagnostics |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Jul 24, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
Intended Use
The TC-Thunderbolt Automated Urine Analyzer System is an in vitto diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
Device Story
Automated urine chemistry analyzer; uses TC-Thunderbolt URS-10 reagent strips. Input: urine sample via automated suction needle/pipe. Operation: reflectance photometry measures color changes on reagent pads; digital analysis determines semi-quantitative results for 10 analytes. Output: printed/saved analysis report. Used in clinical laboratories by trained personnel. Benefits: automates sample application and reading, reducing manual handling compared to predicate. Healthcare providers use results to aid diagnosis of metabolic, renal, urinary, and liver conditions.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated with 3 control levels (20 replicates/level). Linearity/reportable range validated with spiked urine samples. Analytical specificity tested against 19 potential interferents; interference noted for specific analytes (e.g., ascorbic acid, hemoglobin, glucose). Method comparison study performed against predicate (n=487 clinical specimens) showing high agreement (overall exact match >95% for most analytes).
Technological Characteristics
Reflectance photometer; automated sample-suction/strip-application mechanism. Uses 10-pad plastic reagent strips (110mm x 5mm). Calibration via dedicated calibration strip. Connectivity includes barcode scanner for specimen ID. Software-controlled analysis. Operates at 25°C ± 5°C, <75% humidity.
Indications for Use
Indicated for clinical laboratory use to automate urine chemistry analysis for semi-quantitative measurement of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine to aid in diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Not for Point of Care use.
Regulatory Classification
Identification
A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
Predicate Devices
- Uritek-720+ Urine Analyzer with Teco Diagnostic URS-10 strips (k051526)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
TECO DIAGNOSTICS AQUIL MERCHANT RESEARCH SCIENTIST 1268 NORTH LAKEVIEW AVE. ANAHEIM CA 92807
Re: K141289
Trade/Device Name: TC-Thunderbolt Automated Urine Analyzer System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIO, KQO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB Dated: July 17, 2015 Received: July 20, 2015
Dear Mr. Merchant:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
# Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
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| TC-Thunderbolt Automated Urine Analyzer System<br>Device Name | | |
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| 88 1885 888 8886 (88 | ้างอิง<br>ပြုဝါ ခရိုင်များ | PSC Publishing Services (301) 443-6740<br>नान |
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#### 510(k) Summary
#### Applicant:
510(k) Number: k141289 Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807
Aquil Merchant, M.S., Research Scientist Tel: 714.463.1111 | Fax: 714.463.1169 Email: amerchant@tecodiag.com | Web: http://www.tecodiag.com Date: 07/24/2015
#### 4.1) TC-Thunderbolt Automated Urine Analyzer System:
#### A) Proprietary and Established Names:
Proprietary Names: TC-Thunderbolt Automated Urine Analyzer System
Common Names: Automated Urine Analyzer, Urine Test System (non-quantitative). The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.
| Regulation section | Code | Test | Classification |
|--------------------|------|--------------------------------------------------------------------|----------------|
| 21 CFR § 862.1340 | JIL | Urinary Glucose (nonquantitative) Test System | II |
| 21 CFR § 864.6550 | JIO | Occult Blood Test | II |
| 21 CFR § 862.2900 | KQO | Automated Urinalysis System | I |
| 21 CFR § 864.7675 | LJX | Leukocyte Peroxidase Test | I |
| 21 CFR § 862.2800 | JRE | Refractometer for clinical use | I |
| 21 CFR § 862.1550 | CEN | Urinary pH (nonquantitative) Test System | I |
| 21 CFR § 862.1510 | JMT | Nitrite (nonquantitative) Test System | I |
| 21 CFR § 862.1645 | JIR | Urinary Protein or Albumin (nonquantitative) Test<br>System | I |
| 21 CFR § 862.1435 | JIN | Ketones (nonquantitative) Test System | I |
| 21 CFR § 862.1785 | CDM | Urinary Urobilinogen (nonquantitative) Test System | I |
| 21 CFR § 862.1115 | JJB | Urinary Bilirubin and its conjugates (nonquantitative) Test System | I |
#### 4.2) Regulatory Information:
#### 4.3) Indication for Use:
The TC-Thunderbolt Automated Urine Analyzer System is an in vitto diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
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#### 4.4) Predicate Device:
Uritek-720+ Urine Analyzer for the use with Teco Diagnostic's URS-10 strips (k051526).
#### 4.5) Description of the proposed device:
The proposed device is an automated urine chemistry analyzer system intended for use only with TC-Thunderbolt URS-10 strips for the measurement of ten urine chemistry analytes from the chemistry strip. The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.
| Description | Proposed | Predicate |
|--------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | TC-Thunderbolt Automated<br>Analyzer System | Uritek-720+ Analyzer |
| Intended Use | Automated Urine Chemistry Analyzer used<br>for in vitro measurement of glucose,<br>protein, pH, bilirubin, blood, ketone,<br>urobilinogen, nitrite, specific gravity and<br>leukocytes in urine. | Same |
| Design | Same as predicate | Uses proven chemical test<br>method protocol for the intended<br>use determinations of all 10<br>parameters |
| Design | Same as predicate | Uses the principle of light<br>reflection to determine the color<br>intensity on reagent strip test<br>area |
| Design | Same as predicate | Uses testing technology of a<br>cold light source, integrating<br>sphere and modularized<br>blocking systematical design<br>which enhances the stability of<br>the optical system |
| Design | The test module uses the principle of light-<br>reflection to determine the changes in paper<br>color, conduct a digital analysis on the<br>central portion most uniform in color of the<br>paper | Measures the color intensity by<br>irradiating the white light and<br>detecting the reflectance on the<br>urine pad with an integrated<br>sphere photo-detector |
#### 4.6) TC-Thunderbolt Automated Urine Analyzer System v/s Uritek-720+ Analyzer:
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| Testing Pattern | The test module uses automatic sample-<br>suction, strip advance, and sample-<br>application technologies instead of manual<br>operations to facilitate urinalysis. Transfer<br>of urine sample takes place via a sample-<br>suction needle and pipe which extracts and<br>applies the sample to the test strip | The test strip needs to be dipped<br>in the test tube containing urine<br>sample manually. Dry the strip<br>on an absorbent piece of paper<br>and place it on the test table. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety | The device has been certified to comply<br>with the latest applicable safety standards<br>which includes EN 61010-1:2010 for LVD<br>and EN 61010-2-101: 2002 for IVD | The device has been certified to<br>comply with the latest applicable<br>safety standards which includes<br>EN 61010-1:2010 for LVD and<br>EN 61010-2-101: 2002 for IVD |
| Electromagnetic<br>Compatibility | The proposed device has been tested and<br>certified to EN 61326-1:2006 EMC<br>requirements-general, EN 61326-2-6:2006<br>EMC requirements-particular requirements<br>for IVD medical equipment, EN 61000-3-<br>2:2006 + A1:2009 + A2: 2009 and EN<br>61000-3-3:2008 | The device has been tested and<br>certified to EN 61000-4-2, EN<br>61000-4-4, EN 61000-4-5 and<br>EN 61000-4-11 |
| Chemistry Strips | The TC-Thunderbolt Automated Urine<br>Analyzer System is intended for use only<br>with TC-Thunderbolt URS-10 strips | The Uritek-720+ analyzer is<br>intended for use only with Teco<br>Diagnostic's URS 10 strips |
| Description | TC-Thunderbolt Automated Urine Analyzer System | Teco Diagnostic's URS-10 Strips |
| Intended Specimen | Urine | Same |
| Materials Provided | Plastic strips affixed with reagent pads | Same |
| Dimension | 110mm (length) x 5mm (width) | 108mm (length) x 5mm (width) |
| Glucose Methodology | Based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the reaction in which glucose is oxidized to produce gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen in which the chromogen is oxidized to different colors ranging from blue-green to greenish-brown through brown and dark brown. | Same |
| Bilirubin Methodology | Based on the coupling of bilirubin with a diazotized dichioroaniline in a strongly acid medium. Varying bilirubin levels will produce light tan to reddish brown color proportional to its concentration in urine. | Same |
| Ketone Methodology | Based on the reaction of acetoacetic acid with sodium nitroprusside in a strongly basic medium. The colors range from beige or buff-pink color for a "Negative" reading to pink and pink-purple for a "Positive" reading. | Same |
| Specific Gravity Methodology | Based on the apparent pKa change of certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or blue-green in urine of low ionic concentration to green and yellow-green in urine of higher ionic concentration. | Same |
| Blood Methodology | Based on the pseudoperoxidase action of hemoglobin and erythrocytes which catalyzes the reaction of 3,3', 5, 5 '-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue. | Same |
| pH Methodology | Based on the well-known double pH indicator method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range from red-orange to yellow | Same |
| Protein<br>Methodology | Based on the protein error-of-indicator principle.<br>At a constant pH, the development of any green<br>color is due to the presence of protein. Colors<br>range from yellow for a "Negative" reaction to<br>yellow-green and green to blue-green for a<br>"Positive" reaction. | Same |
| Urobilinogen<br>Methodology | Based on a modified Ehrlich reaction in which p-<br>diethylaminobenzaldehyde<br>reacts<br>with<br>urobilinogen in a strongly acid medium. Colors<br>range from light pink to bright magenta. | Same |
| Nitrite<br>Methodology | This test depends on the conversion of nitrate to<br>nitrite by the action of Gram-negative bacteria in<br>the urine. The nitrite reacts with p-arsanilic acid<br>to from a diazonium compound in an acid<br>medium. The diazoniumn compound in turn<br>couples with 1, 2, 3, 4- tetrahydrobenzo (h)<br>quinolin to produce a pink color. | Same |
| Leukocyte<br>Methodology | Based on the action of esterase present in<br>leukocytes, which catalyzes the hydrolysis of an<br>indoxyl ester derivative. The indoxyl ester<br>liberated reacts with a diazoniumn salt to produce<br>a beige-pink to purple color. | Same |
The TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ analyzer share the same technological characteristics including the testing parameters, print out, calibration method, and power requirements. The most notable difference is in their respective testing patterns, wherein TC-Thunderbolt Automated Urine Analyzer System uses automatic sample-suction, strip advance, and sample-application technologies and for the predicate the test strip needs to be dipped in urine sample and placed on the test table manually. In addition to this, they also differ in their display, user interface, entered parameter (user ID), dimensions and weight. These differences do not have any effect on the results of the devices since the color development and reflectance values are measured after one minute.
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# 4.7) TC-Thunderbolt Automated Urine Analyzer System v/s Teco Diagnostic's URS-10 Strips:
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The TC-Thunderbolt URS-10 Strips and Teco Diagnostic's URS-10 strips share the same characteristics including Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte methodologies. The differences between the TC-Thunderbolt URS-10 Strips and Teco Diagnostic's URS-10 strips could be the length of the strip, paper of reagent pad and black plastic pad. The TC-Thunderbolt URS-10 strips are 2mm longer in length and have a black plastic pad at the end which is meant only for alignment purpose in the TC-Thunderbolt Automated Urine Analyzer System. However these differences do not have any effect on the results or operations of the devices.
#### 4.8) Test Principle:
Glucose: This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the reaction in which glucose is oxidized to produce gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen in which the chromogen is oxidized to different colors ranging from blue-green to greenishbrown through brown and dark brown.
Bilirubin: This test is based on the coupling of bilirubin with a diazotized dichioroaniline in a strongly acid medium. Varying bilirubin levels will produce light tan to reddish brown color proportional to its concentration in urine.
Ketone: This test is based on t reaction of acetoacetic acid with sodium n basic medium. The colors range from beige or buff-pink color for a "Negative" reading to pinkpurple for a "Positive" reading.
Specific Gravity: This test is based on the apparent pKa change of certai relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or
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blue-green in urine of low ionic concentration to green and yellow-green in urine of higher ionic concentration.
Blood: This test is based on the pseudoperoxidase action of hemoglobin and erythrocytes which catalyzes the reaction of 3,3', 5, 5 '-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue.
pH: This test is based on the well-known double pH indicator method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range to yellow and yellow-green to blue-green.
Protein: This test is based on the protein error-of-indicator principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a "Negative" reaction to yellow-green and green to blue-green for a "Positive" reaction.
Urobilinogen: This test is based on a modified Ehrlich reaction in which p-diethylaminobenzaldehyde reacts with urobilinogen in a strongly acid medium. Colors range from light pink to bright magenta.
Nitrite: This test depends on the conversion of nitrate to nitrite by the action of Gram-negative bacteria in the urine. The nitrite reacts with p-arsanilic acid to from a diazonium compound in an acid medium. The diazoniumn compound in turn couples with 1, 2, 3, 4- tetrahydrobenzo(h) quinolin to produce a pink color.
Leukocytes: This test is based on the action of esterase present in leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. The indoxyl ester liberated reacts with a diazoniumn salt to produce a beige-pink to purple color.
### 4.9) Analytical Performance Studies
#### A) Precision Study Summary:
- > Within Run:
Repeatability (within run and day-to-day) precision of the TC-Thunderbolt Automated Urine Analyzer System was evaluated using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative). The package insert and certificate of analysis of these control solutions confirmed the specific target analyte concentration in each level. 20 replicate assays of each level (negative, and high positive) were analyzed on TC-Thunderbolt Automated Urine Analyzer with three lots of TC-Thunderbolt URS-10 strips by three operators. A total of 60 strips were used for each level control solution tested (20 strips x 1 day x 3 operators/strip lots = 60 tests per control). The results from the Within Run Precision study are summarized below:
| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|-----------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | 500 mg/dL | 58/60 | 96.67 | 60/60 | 100 | 60 |
| Bilirubin | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
#### Urine Control Level I
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| Specific Gravity | 1.015 | 60/60 | 100 | 60/60 | 100 | 60 |
|------------------|-----------|-------|-------|-------|-----|----|
| Blood | Moderate | 59/60 | 98.34 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | 300 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 8 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
# Urine Control Level II
| Analyte | Level | Exact<br>Match<br>Agreement | %Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | %Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|-----------------------------|---------------------------------|------------------------------------|----|
| Glucose | 100 mg/dL | 58/60 | 96.67 | 60/60 | 100 | 60 |
| Bilirubin | Small | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 59/60 | 98.83 | 60/60 | 100 | 60 |
| Specific Gravity | 1.015 | 57/60 | 95 | 60/60 | 100 | 60 |
| Blood | Trace | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Small | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
# Urine Control Level III
| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | Negative | 59/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.005 | 58/60 | 96.67 | 60/60 | 100 | 60 |
| Blood | Negative | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 6.5 | 58/60 | 96.67 | 60/60 | 100 | 60 |
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### > Run to Run:
TC-Thunderbolt Automated Urine Analyzer was evaluated by testing each control level (negative, low positive, and high positive) by three operators with three lots of TC-Thunderbolt URS-10 strips in two replicate assays for 2 non- consecutive runs/day over 5 days. Run 1 and Run 2 were separated by atleast 1 hour. A total of 60 strips were used for each level control solution tested (2 strips x 2 run x 5 days x 3 operators/ strip lots = 60 tests per control). The results from the Run to Run Precision study are summarized below:
### Urine Control Level I
| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | %<br>Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|----------------------------------------|----|
| Glucose | 500 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.015 | 59/60 | 98.83 | 60/60 | 100 | 60 |
| Blood | Moderate | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | 300 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 8 EU/dL | 59/60 | 98.83 | 60/60 | 100 | 60 |
| Leukocyte | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
### Urine Control Level II
| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | 100 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Small | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.015 | 56/60 | 93.34 | 60/60 | 100 | 60 |
| Blood | Trace | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Small | 58/60 | 96.67 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
{11}------------------------------------------------
#### Urine Control Level III
| Analyte | Level | Exact<br>Match<br>Agreement | % Agreement<br>(Exact Match) | +/- Color<br>Block<br>Agreement | % Agreement<br>(+/- Color<br>Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.005 | 60/60 | 100 | 60/60 | 100 | 60 |
| Blood | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 6.5 | 60/60 | 100 | 60/60 | 100 | 60 |
#### B) Method Comparison Study Summary:
This comparison study testing was performed at Teco Diagnostics, Anaheim CA in United States. The urine samples for analysis in these method comparison studies were provided by external clinical sites. Samples were collected within 4 hours of testing if maintained at room temperature or were stored for up to 8 hours prior to testing if maintained at 2-8°C. In order to obtain a desired range of abnormal values a pool of negative urine samples were spiked to elevated level with the analytes to be evaluated. These spiked samples represent 10% of the total samples tested. For each chemistry analyte, the values obtained for the individual urine samples were referred to the respective cut-off values for each system to discriminate between the negative (normal) and positive (abnormal) findings, if applicable. The data was represented in concordance charts showing percent exact match agreement and percent agreement within 1 color block.
| Glucose | | | | | | |
|-------------------------------|--------|--------|--------|--------|--------|---------|
| Thunderbolt<br>Uritek-720+ | 1000 | 500 | 250 | 100 | Neg | Overall |
| 1000 | 11 | | | | | |
| 500 | | 19 | 4 | | | |
| 250 | | 3 | 22 | 1 | | |
| 100 | | | | 4 | | |
| Neg | | | | | 423 | |
| Total | 11 | 22 | 26 | 5 | 423 | 487 |
| % Agreement (Exact Match) | 100.00 | 86.36 | 84.62 | 80.00 | 100.00 | 98.36 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Glucose concentration levels compared at a 98.36% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
{12}------------------------------------------------
| Bilirubin | Uritek-720+ | 3+ | 2+ | 1+ | Neg | Overall |
|-------------------------------|-------------|--------|--------|--------|--------|---------|
| Thunderbolt | | | | | | |
| 3+ | | 6 | | | | |
| 2+ | | | 7 | | | |
| 1+ | | | | 40 | | |
| Neg | | | | 2 | 432 | |
| Total | | 6 | 7 | 42 | 432 | 487 |
| % Agreement (Exact Match) | | 100.00 | 100.00 | 95.24 | 100.00 | 99.59 |
| % Agreement (+/- Color Block) | | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Bilirubin concentration levels compared at a 99.59% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Ketone | | | | | | | |
|-------------|-------------------------------|--------|--------|--------|--------|--------|---------|
| | Uritek-720+ | 80 | 40 | 15 | TRA | Neg | Overall |
| Thunderbolt | 80 | 6 | | | | | |
| | 40 | | 10 | 3 | | | |
| | 15 | | 3 | 25 | 2 | | |
| | TRA | | | 2 | 14 | 1 | |
| | Neg | | | | | 421 | |
| | Total | 6 | 13 | 30 | 16 | 422 | 487 |
| | % Agreement (Exact Match) | 100.00 | 76.92 | 83.33 | 87.50 | 99.76 | 97.74 |
| | % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Ketone concentration levels compared at a 97.74% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Specific Gravity | | | | | | | |
|-------------------------------|--------|--------|--------|-------|--------|--------|---------|
| Uritek-720+<br>Thunderbolt | >1.030 | 1.025 | 1.020 | 1.015 | 1.010 | <1.005 | Overall |
| >1.030 | 9 | 1 | | | | | |
| 1.025 | 3 | 118 | 12 | | | | |
| 1.020 | | 5 | 44 | 4 | | | |
| 1.015 | | | 7 | 101 | 3 | 2 | |
| 1.010 | | | | 30 | 68 | 5 | |
| <1.005 | | | | 2 | 24 | 49 | |
| Total | 12 | 124 | 63 | 137 | 95 | 56 | 487 |
| % Agreement (Exact Match) | 75.00 | 95.16 | 69.84 | 73.72 | 71.58 | 87.50 | 79.88 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 98.54 | 100.00 | 96.43 | 99.18 |
Specific Gravity concentration levels compared at a 79.88% overall exact match and a 99.18% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer. * The Acceptance Criteria for SG is +/- 0.005.
{13}------------------------------------------------
| Blood | | | | | | |
|-------------------------------|--------|--------|--------|--------|--------|---------|
| Uritek-720+<br>Thunderbolt | 3+ | 2+ | 1+ | TRA | Neg | Overall |
| 3+ | 13 | 3 | | | | |
| 2+ | 1 | 45 | 6 | | | |
| 1+ | | 4 | 20 | 5 | | |
| TRA | | | | 17 | 1 | |
| Neg | | | | 2 | 370 | |
| Total | 14 | 52 | 26 | 24 | 371 | 487 |
| % Agreement (Exact Match) | 92.86 | 86.54 | 76.92 | 70.83 | 99.73 | 95.48 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Blood concentration levels compared at a 95.48% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Protein | | | | | | | |
|-------------------------------|--------|--------|--------|--------|--------|---------|--|
| Thunderbolt<br>Uritek-720+ | >300 | 100 | 30 | TRA | Neg | Overall | |
| >300 | 40 | 3 | | | | | |
| 100 | 3 | 32 | | | | | |
| 30 | | | 17 | | | | |
| TRA | | | 3 | 20 | | | |
| Neg | | | | 1 | 368 | | |
| Total | 43 | 35 | 20 | 21 | 368 | 487 | |
| % Agreement (Exact Match) | 93.02 | 91.43 | 85.00 | 95.24 | 100.00 | 97.95 | |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | |
Protein concentration levels compared at a 97.95% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Urobilinogen | | | | | | |
|-------------------------------|--------|--------|--------|--------|--------|---------|
| Thunderbolt<br>Uritek-720+ | >8.0 | 4 | 2 | 1 | 0.2 | Overall |
| >8.0 | 10 | 1 | | | | |
| 4.0 | 1 | 66 | 4 | | | |
| 2.0 | | 1 | 27 | 1 | | |
| 1.0 | | | | 31 | 13 | |
| 0.2 | | | | | 332 | |
| Total | 11 | 68 | 31 | 32 | 345 | 487 |
| % Agreement (Exact Match) | 90.91 | 97.06 | 87.10 | 96.88 | 96.23 | 95.69 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Urobilinogen concentration levels compared at a 95.69% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
{14}------------------------------------------------
| pH | | | | | | | | |
|-------------------------------|-----|-----|--------|--------|-------|-------|--------|---------|
| Thunderbolt<br>Uritek-720+ | 8.5 | 8 | 7.5 | 7.0 | 6.5 | 6.0 | 5.0 | Overall |
| 8.5 | 10 | | | | | | | |
| 8.0 | | 12 | | | | | | |
| 7.5 | | | 111 | 4 | 1 | | | |
| 7.0 | | | 3 | 59 | 2 | 1 | | |
| 6.5 | | | | 3 | 94 | 33 | | |
| 6.0 | | | | | | 64 | 18 | |
| 5.0 | | | | | | 1 | 71 | |
| Total | 10 | 12 | 114 | 66 | 97 | 99 | 89 | 487 |
| % Agreement (Exact Match) | 100 | 100 | 97.37 | 89.39 | 96.91 | 64.65 | 79.78 | 86.45 |
| % Agreement (+/- Color Block) | 100 | 100 | 100.00 | 100.00 | 98.97 | 98.99 | 100.00 | 99.59 |
pH concentration levels compared at an 86.45% overall exact match and a 99.59% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Nitrite | Uritek-720+ | + | - | Overall |
|-------------------------------|-------------|--------|--------|---------|
| Thunderbolt | + | 70 | | |
| | - | 1 | 416 | |
| Total | | 71 | 416 | 373 |
| % Agreement (Exact Match) | | 98.59 | 100.00 | 99.79 |
| % Agreement (+/- Color Block) | | 100.00 | 100.00 | 100.00 |
Nitrite concentration levels compared at a 99.79% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Leukocyte | | | | | | |
|-------------------------------|--------|--------|-------|--------|--------|---------|
| Thunderbolt<br>Uritek-720+ | 3+ | 2+ | 1+ | TRA | Neg | Overall |
| 3+ | 12 | | | | | |
| 2+ | 1 | 17 | 4 | | | |
| 1+ | | 5 | 27 | 5 | | |
| TRA | | | 1 | 15 | | |
| Neg | | | | | 400 | |
| Total | 13 | 22 | 32 | 20 | 400 | 487 |
| % Agreement (Exact Match) | 92.31 | 77.27 | 84.38 | 75.00 | 100.00 | 96.71 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 96.88 | 100.00 | 100.00 | 100.00 |
Leukocyte concentration levels compared at a 96.71% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
{15}------------------------------------------------
#### C) Sensitivity/ Cutoff Point Determination Study Summary
#### A Sensitivity Study
Sensitivity Study was performed to determine the cutoff point concentration at which each analyte on the TC-Thunderbolt URS-10 strip changed from negative to the positive color blocks. Samples were prepared by spiking the specified analyte concentration into negative urine with a minimum of 4 levels across the measuring range for each color block. Each pool was then analyzed in replicates of 7 by 3 operators on each of the 3 individual strip lots (7 strips x 3 operators/ strip lots), for a total of 21 data points for each level. The cutoff point determination study for each color block for each analyte is defined as the lowest concentration at which >55% of the test results are positive.
#### Results:
The cut-off values and percentage sensitivity for each color block for individual analyte is summarized and demonstrated in the table below:
| Analyte | Color Block | Cut-off Concentration | % Positive Results |
|-----------|-------------|-----------------------|--------------------|
| Glucose | 100 mg/dL | 75 mg/dL | 90% |
| | 250 mg/dL | 212.5 mg/dL | 85% |
| | 500 mg/dL | 437.5 mg/dL | 85% |
| | 1000 mg/dL | 875 mg/dL | 85% |
| Bilirubin | Small | 0.375 mg/dL | 57% |
| | Moderate | 1 mg/dL | 100% |
| | Large | 2.5 mg/dL | 57% |
| Ketone | Trace | 3.75 mg/dL | 95% |
| | 15 mg/dL | 10 mg/dL | 55% |
| | 40 mg/dL | 27.5 mg/dL | 55% |
| 80 mg/dL | 60 mg/dL | 95% | |
| Blood | Trace | 0.023 mg/dL | 61% |
| | Small | 0.064 mg/dL | 76% |
| | Moderate | 0.199 mg/dL | 90% |
| | Large | 0.628 mg/dL | 90% |
| Protein | Trace | 11.25 mg/dL | 75% |
| | 30 mg/dL | 26.25 mg/dL | 85% |
| | 100 mg/dL | 82.5 mg/dL | 95% |
| | 300 mg/dL | 200 mg/dL | 85% |
| | 2000 mg/dL | 1150 mg/dL | 70% |
| Nitrite | Positive | 0.1 mg/dL | 55% |
| Leukocyte | Trace | 15 ca cells/µL | 100% |
| | Small | 56.25 ca cells/µL | 95% |
| | Moderate | 97.5 ca cells/µL | 60% |
{16}------------------------------------------------
| | Large | 406.25 ca cells/µL | 55% |
|--------------|-----------|--------------------|------|
| Urobilinogen | 0.2 mg/dL | 0.2 mg/dL | 100% |
| | 1.0 mg/dL | 0.8 mg/dL | 71% |
| | 2.0 mg/dL | 2.0 mg/dL | 90% |
| | 4.0 mg/dL | 3.5 mg/dL | 55% |
| | 8.0 mg/dL | 7.0 mg/dL | 85% |
| | pH | 5.0 | 5.0 |
| 6.0 | | 6.0 | 95% |
| 6.5 | | 6.5 | 95% |
| 7.0 | | 7.0 | 95% |
| 7.5 | | 7.5 | 95% |
| 8.0 | | 8.0 | 100% |
| 8.5 | | 8.5 | 100% |
| SG | 1.005 | 1.005 | 100% |
| | 1.010 | 1.010 | 100% |
| | 1.015 | 1.015 | 100% |
| | 1.020 | 1.020 | 100% |
| | 1.025 | 1.025 | 100% |
| | 1.030 | 1.030 | 100% |
The results for specific analyte concentration at each color block are shown below:
| | Concentration<br>Tested | Percentage Agreement at Each Color Block | | | | |
|---------|-------------------------|------------------------------------------|-----------|-----------|-----------|------------|
| | | Negative | 100 mg/dL | 250 mg/dL | 500 mg/dL | 1000 mg/dL |
| GLUCOSE | 25 mg/dL | 100% | 0% | 0% | 0% | 0% |
| | 50 mg/dL | 100% | 0% | 0% | 0% | 0% |
| | 75 mg/dL | 10% | 90% | 0% | 0% | 0% |
| | 100 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 137.5 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 175 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 212.5 mg/dL | 0% | 15% | 85% | 0% | 0% |
| | 250 mg/dL | 0% | 0% | 100% | 0% | 0% |
{17}------------------------------------------------
| 312.5 mg/dL | 0% | 0% | 100% | 0% | 0% |
|-------------|----|----|------|------|------|
| 375 mg/dL | 0% | 0% | 100% | 0% | 0% |
| 437.5 mg/dL | 0% | 0% | 15% | 85% | 0% |
| 500 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 625 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 750 mg/dL | 0% | 0% | 0% | 60% | 40% |
| 875 mg/dL | 0% | 0% | 0% | 15% | 85% |
| 1000 mg/dL | 0% | 0% | 0% | 0% | 100% |
| | Concentration<br>Tested | Percentage Agreement at Each Color Block | | | |
|-----------|-------------------------|------------------------------------------|-------|----------|-------|
| | | Negative | Small | Moderate | Large |
| | 0.125 mg/dL | 100% | 0% | 0% | 0% |
| | 0.25 mg/dL | 100% | 0% | 0% | 0% |
| | 0.375 mg/dL | 43% | 57% | 0% | 0% |
| | 0.5 mg/dL | 0% | 100% | 0% | 0% |
| BILIRUBIN | 0.625 mg/dL | 0% | 100% | 0% | 0% |
| | 0.75 mg/dL | 0% | 100% | 0% | 0% |
| | 0.875 mg/dL | 0% | 71% | 29% | 0% |
| | 1 mg/dL | 0% | 0% | 100% | 0% |
| | 1.5 mg/dL | 0% | 0% | 100% | 0% |
| | 2 mg/dL | 0% | 0% | 100% | 0% |
| | 2.5 mg/dL | 0% | 0% | 43% | 57% |
| | 3 mg/dL | 0% | 0% | 0% | 100% |
| | Concentration<br>Tested | Percentage Agreement at Each Color Block | | | | |
|--------|-------------------------|------------------------------------------|-------|----------|----------|----------|
| | | Negative | Trace | 15 mg/dL | 40 mg/dL | 80 mg/dL |
| KETONE | 1.25 mg/dL | 100% | 0% | 0% | 0% | 0% |
| | 2.5 mg/dL | 85% | 15% | 0% | 0% | 0% |
| | 3.75 mg/dL | 5% | 95% | 0% | 0% | 0% |
{18}------------------------------------------------
| 5 mg/dL | 0% | 100% | 0% | 0% | 0% |
|-------------|----|------|------|------|------|
| 7.5 mg/dL | 0% | 100% | 0% | 0% | 0% |
| 10 mg/dL | 0% | 45% | 55% | 0% | 0% |
| 12.5 mg/dL | 0% | 10% | 90% | 0% | 0% |
| 15 mg/dL | 0% | 0% | 100% | 0% | 0% |
| 21.5 mg/dL | 0% | 0% | 90% | 10% | 0% |
| 27.5 mg/dL | 0% | 0% | 45% | 55% | 0% |
| 33.75 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 40 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 50 mg/dL | 0% | 0% | 0% | 60% | 40% |
| 60 mg/dL | 0% | 0% | 0% | 5% | 95% |
| 70 mg/dL | 0% | 0% | 0% | 0% | 100% |
| 80 mg/dL | 0% | 0% | 0% | 0% | 100% |
| | Concentration<br>Tested | Percentage Agreement at Each Color Block | | | | |
|-------|-------------------------|------------------------------------------|-------|-------|----------|-------|
| | | Negative | Trace | Small | Moderate | Large |
| BLOOD | 0.008 mg/dL | 90% | 10% | 0% | 0% | 0% |
| | 0.015 mg/dL | 81% | 19% | 0% | 0% | 0% |
| | 0.023 mg/dL | 29% | 61% | 0% | 0% | 0% |
| | 0.03 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 0.043 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 0.053 mg/dL | 0% | 90% | 10% | 0% | 0% |
| | 0.064 mg/dL | 0% | 24% | 76% | 0% | 0% |
| | 0.075 mg/dL | 0% | 0% | 100% | 0% | 0% |
| | 0.116 mg/dL | 0% | 0% | 100% | 0% | 0% |
| | 0.158 mg/dL | 0% | 0% | 100% | 0% | 0% |
| | 0.199 mg/dL | 0% | 0% | 10% | 90% | 0% |
| | 0.24 mg/dL | 0% | 0% | 0% | 100% | 0% |
| | 0.368 mg/dL | 0% | 0% | 0% | 100% | 0% |
{19}------------------------------------------------
| 0.495 mg/dL | 0% | 0% | 0% | 100% | 0% |
|-------------|----|----|----|------|------|
| 0.628 mg/dL | 0% | 0% | 0% | 10% | 90% |
| 0.75 mg/dL | 0% | 0% | 0% | 0% | 100% |
| | Concentration<br>Tested | Percentage Agreement at Each Color Block | | | | | |
|---------|-------------------------|------------------------------------------|-------|-------------|--------------|--------------|---------------|
| | | Negative | Trace | 30<br>mg/dL | 100<br>mg/dL | 300<br>mg/dL | 2000<br>mg/dL |
| | 3.75 mg/dL | 100% | 0% | 0% | 0% | 0% | 0% |
| | 7.5 mg/dL | 55% | 45% | 0% | 0% | 0% | 0% |
| | 11.25 mg/dL | 25% | 75% | 0% | 0% | 0% | 0% |
| | 15 mg/dL | 0% | 100% | 0% | 0% | 0% | 0% |
| | 18.75 mg/dL | 0% | 90% | 10% | 0% | 0% | 0% |
| | 22.5 mg/dL | 0% | 20% | 80% | 0% | 0% | 0% |
| PROTEIN | 26.25 mg/dL | 0% | 15% | 85% | 0% | 0% | 0% |
| | 30 mg/dL | 0% | 0% | 100% | 0% | 0% | 0% |
| | 47.5 mg/dL | 0% | 0% | 100% | 0% | 0% | 0% |
| | 65 mg/dL | 0% | 0% | 5% | 95% | 0% | 0% |
| | 82.5 mg/dL | 0% | 0% | 5% | 95% | 0% | 0% |
| | 100 mg/dL | 0% | 0% | 0% | 100% | 0% | 0% |
| | 150 mg/dL | 0% | 0% | 0% | 80% | 20% | 0% |
| | 200 mg/dL | 0% | 0% | 0% | 15% | 85% | 0% |
| | 250 mg/dL | 0% | 0% | 0% | 5% | 95% | 0% |
| | 300 mg/dL | 0% | 0% | 0% | 0% | 100% | 0% |
| | 725 mg/dL | 0% | 0% | 0% | 0% | 55% | 45% |
| | 1150 mg/dL | 0% | 0% | 0% | 0% | 30% | 70% |
| | 1575 mg/dL | 0% | 0% | 0% | 0% | 10% | 90% |
| | 2000 mg/dL | 0% | 0% | 0% | 0% | 0% | 100% |
{20}------------------------------------------------
| | Concentration<br>Tested (ca<br>cells/µL) | Percentage Agreement at Each Color Block | | | | |
|------------|------------------------------------------|------------------------------------------|-------|-------|----------|-------|
| | | Negative | Trace | Small | Moderate | Large |
| LEUKOCYTES | 3.75 | 100% | 0% | 0% | 0% | 0% |
| | 7.5 | 100% | 0% | 0% | 0% | 0% |
| | 11.25 | 95% | 5% | 0% | 0% | 0% |
| | 15…
