CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

K032437 · Roche Diagnostics Corp. · JIL · Oct 8, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032437
• Device Name: CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
• Applicant: Roche Diagnostics Corp.
• Product Code: JIL · Clinical Chemistry
• Decision Date: Oct 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2

Intended Use

Multi-parameter test strips to measure certain constituents in the urine either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Chemstrip 5OB, 7 and 10 MD urine test strips are inert plastic strips to which are attached different reagent pads for determining specific gravity, pH, indication leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine.

Device Story

Chemstrip 5OB, 7, and 10 MD are multi-parameter urinalysis test strips; inert plastic strips with reagent pads. Input: urine sample applied to pads. Operation: colorimetric/reflectance-based chemical reactions on pads; pads change color based on analyte concentration. Output: visual color comparison or reflectance values measured by Chemstrip 101 or Criterion II analyzers. Used in clinical settings; operated by healthcare professionals. Analyzers process reflectance data to determine analyte levels; results assist clinicians in evaluating renal, urinary, and metabolic disorders. Benefits: rapid, standardized screening for multiple urine constituents.

Clinical Evidence

Bench testing only. Sensitivity data provided for Chemstrip 101 and Criterion II analyzers using contrived urine pools. Results show detectable analyte levels consistent with clinical requirements for urinalysis testing.

Technological Characteristics

Inert plastic strips with reagent pads attached via nylon mesh; some pads include inert absorbent paper. Sensing principle: colorimetric/reflectance. Analyzers use reflectance photometry. Parameters: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood/hemoglobin. Standalone operation or integrated with Chemstrip 101/Criterion II analyzers.

Indications for Use

Indicated for use in patients requiring evaluation of renal, urinary, and metabolic disorders via urinalysis. Applicable for visual or automated (Chemstrip 101/Criterion II) measurement of urine constituents including specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, and blood/hemoglobin.

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

• Bayer Multistix® 10 SG for use on the Clinitek 50 Urine Analyzer (K960546)

Submission Summary (Full Text)

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OCT - 8 2003

510(k) Summary

K032437

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter<br>name, address,<br>contact | Roche Diagnostics Corporation<br>9115 Hague Rd.<br>Indianapolis, IN 46250 |
| | Contact Person: Jennifer Tribbett<br>Date Prepared: August 4, 2003 |
| 2) Device name | Proprietary name: Chemstrip® 5 OB, Chemstrip® 7 and Chemstrip® 10<br>MD test strips<br>Common and Classification name: Urinary test system |
| 3) Predicate<br>device | The Chemstrip 5 OB, 7 and 10 MD test strips are equivalent to other<br>urinalysis strips such as Bayer Multistix® 10 SG for use on the Clinitek 50<br>Urine Analyzer (K960546). |
| 4) Device<br>Description | The Chemstrip 5 OB test strip is a multi-parameter urinalysis test strip, which<br>measures leukocytes, blood/hemoglobin, nitrite, protein and glucose in the<br>urine. |
| | The Chemstrip 7 test strip is a multi-parameter urinalysis test strip, which<br>measures pH, ketone, leukocytes, blood/hemoglobin, nitrite, protein and<br>glucose in the urine. |
| | The Chemstrip 10 MD test strip is a multi-parameter urinalysis test strip which<br>measures specific gravity, pH, ketones, leukocytes, blood/hemoglobin, nitrite,<br>protein, urobilinogen, bilirubin and glucose in the urine. |
| 5) Intended<br>use | Multi-parameter test strips to measure certain constituents in the urine either<br>visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or<br>Criterion II Urine Analyzer. These measurements are useful in the evaluation of<br>renal, urinary and metabolic disorders. Chemstrip® 5 OB, 7 and 10 MD urine<br>test strips are inert plastic strips to which are attached different reagent pads for<br>determining specific gravity, pH, indication of leukocytes, nitrite, protein,<br>glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine. |

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6) Substantial The table shown below describes the similarities and differences between the equivalence -Chemstrip 10 MD Urine Test Strip and the Chemstrip 5 OB and Chemstrip 7 Similarities and urine test strips. Differences

| Feature | Chemstrip 10 MD Test Strips for use on the<br>Chemstrip 101 Urine Analyzer (K983510) | Chemstrip 5 OB & 7<br>Test Strips for use on the<br>Chemstrip 101 Urine Analyzer |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use | The Chemstrip 10 MD urine test strip is a multi-<br>parameter test strip used to measure certain<br>constituents in the urine either visually or on the<br>Roche Diagnostics Chemstrip 101 Urine Analyzer.<br>These measurements are useful in the evaluation of<br>renal, urinary and metabolic disorders. | Same |
| Constituents<br>Detected | Specific Gravity, Leukocytes, Nitrite, pH, Protein,<br>Glucose, Ketones, Urobilinogen, Bilirubin, Blood | Reduced number of parameters |

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-Continued-

| Feature | Chemstrip® 10 MD Test Strips for use on the<br>Chemstrip 101 Urine Analyzer (K983510) | Chemstrip® 5 OB & 7<br>Test Strips for use on the<br>Chemstrip 101 Urine Analyzer | | |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--|--|
| Test<br>Principle | Specific Gravity: In the presence of cations, protons<br>are released by a complexing agent and produce a<br>color change of the bromthymol blue indicator. | Not offered on the 5 or 7 | | |
| | Leukocytes: Leukocytes in urine are detected by the<br>action of esterase, present in granulocytic leukocytes,<br>which catalyzes the hydrolysis of an indoxylcarbonic<br>acid ester to indoxyl. The indoxyl formed reacts with<br>a diazonium salt to produce a color change. | Same | | |
| | Nitrite: Nitrite reacts with an aromatic amine to give<br>a diazonium salt, which by coupling with a further<br>compound, yields a red-violet azo dye. | Same | | |
| | pH: The test strip contains the indicators methyl red<br>bromthymol blue.<br>These give clearly<br>and<br>distinguishable colors over the pH range of 5-9. | Same as the 7, but not offered on the 5 | | |
| | The detection of protein is based on the<br>Protein:<br>"protein error of pH indicators". The indicator<br>3',3",5',5"-tetrachlorophenol-3,4,5,6-<br>tetrabromosulfophthalein yields a color change in a<br>positive reaction. | Same | | |
| | Glucose detection is based on the<br>Glucose:<br>enzymatic glucose oxidase/peroxidase (GOD/POD)<br>method. | Same | | |
| | Sodium nitroprusside and glycine react<br>Ketones:<br>with acetoacetate and acetone in an alkaline medium<br>to form a violet dye complex. | Same as the 7, but not offered on the 5 | | |

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-Continued-

| Feature | Chemstrip® 10 MD Test Strips for use on the<br>Chemstrip 101 Urine Analyzer (K983510) | Chemstrip® 5 OB & 7<br>Test Strips for use on the<br>Chemstrip 101 Urine Analyzer |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Test<br>Principle | Urobilinogen: Urobilinogen is coupled with 4-<br>methoxybenzene-diazonium-tetrafluoroborate in an<br>acid medium to form a red azo dye. | Not offered on the 5 or 7 |
| | Bilirubin: Bilirubin detection is based on the<br>coupling reaction of a diazonium salt (2,6-<br>dichlorobenzene-diazonium-tetrafluoroborate) with<br>bilirubin in an acid medium which yields a color<br>change. | Not offered on the 5 or 7 |
| | Blood: The chemical detection of blood is based on<br>the strong pseudoperoxidase action of erythrocytes<br>and hemoglobin. Hemoglobin and myoglobin, if<br>present, catalyze the oxidation of the indicator by the<br>organic peroxide contained in the test paper. Intact<br>erythrocytes hemolyze on the test paper and the<br>liberated hemoglobin produces a green dot. | Same |
| Test Pad | The test papers are attached to the strip with a nylon<br>mesh and certain test papers have an inert absorbent<br>paper located between the test area and the strip. | Same |

______________________________________________________________________________________________________________________________________________________________________________

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| Device | The table shown below describes the similarities and differences between the |
|------------------|------------------------------------------------------------------------------|
| Similarities and | Chemstrip 5 OB, Chemstrip 7 and Chemstrip 10 MD urine test strips and the |
| Differences | Bayer Multistix® 10 SG for use on the Clinitek 50 Urine Analyzer (K960546). |

| Feature | Chemstrip® 5 OB, Chemstrip® 7 and<br>Chemstrip® 10 MD Test Strips for use | | | Baver Multistix® 10 SG for use on the<br>Clinitek 50 Urine Analyzer K960546 | |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | on the Chemstrip 101 Urine Analyzer | | | | |
| Intended Use | | Chemstrip 101 Urine Analyzer.<br>renal, urinary and metabolic disorders. | The Chemstrip 5OB, 7 and 10 MD urine test<br>strip are multi-parameter test strips used to<br>measure certain constituents in the urine<br>either visually or on the Roche Diagnostics<br>These<br>measurements are useful in the evaluation of | The<br>Chemistry Analyzers. | Bayer Diagnostics Reagent Strips<br>for<br>Urinalysis are multi-parameter strips used to<br>measure certain constituents in urine either<br>visually or using the Clinitek family of Urine |
| Constituents<br>detected | of<br>Specific<br>Combinations<br>Gravity,<br>Leukocytes, Nitrite, pH, Protein, Glucose,<br>Ketones, Urobilinogen, Bilirubin, Blood | | | | Same |
| Sensitivity<br>Claims | following<br>table summarizes<br>The<br>the<br>sensitivity data obtained with the Chemstrip<br>Criterion II Urine Analyzer and the Chemstrip<br>101 Urine Analyzer. This table lists the level<br>of analyte that is generally detectable as<br>positive when tested with a contrived urine<br>Because of inherent variability in<br>pool.<br>clinical urines, lower levels may be detected<br>under certain conditions.<br>(Note: Criterion II information remains the<br>same as previously indicated in the Chemstrip<br>10 MD insert) | | | The following table lists the generally detectable<br>levels of analytes in contrived urine; however,<br>because of the inherent variability of clinical<br>urines, lesser concentrations may be detected<br>under certain conditions. | |
| | Reagent | Criterion II | Chemstrip 101 | Reagent | Sensitivity |
| | Bilirubin<br>Blood<br>Glucose<br>Ketone<br>Leukocytes<br>Nitrite<br>Protein<br>Urobilinogen | 1.0 mg/dL<br>5 Ery/uL<br>40 mg/dL<br>5 mg/dL<br>25 Leu/uL<br>0.05 mg/dL<br>18 mg/dL<br>0.4 mg/dL | 0.8 - 1.5 mg/dL<br>5 - 20 Ery/uL<br>30 - 40 mg/dL<br>5 - 15 mg/dL<br>30 - 35 Leu/uL<br>0.06 - 0.10 mg/dL<br>25 - 32 mg/dL<br>1 - 2 mg/dL | Glucose<br>Bilirubin<br>Ketone<br>Blood<br>Protein<br>Nitrite<br>Leukocytes | 75-125 mg/dL glucose<br>0.4-0.8 mg/dL bilirubin<br>5-10 mg/dL acetoacetic acid<br>0.015-0.062 mg/dL hemoglobin<br>15-30 mg/dL albumin<br>0.06-0.1 mg/dL nitrite ion<br>5-15 cells/hpf in clinical urine |

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 8 2003

Ms. Jennifer Tribbett Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: k032437

Trade/Device Name: Chemstrip® 5 OB, 7 and 10 MD Urine Test Strips Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: JIL: JRE; CEN; LJX; JIO: JMT; JIN; JJB; CDM; JIR Dated: August 4, 2003 Received: August 7, 2003

Dear Ms. Tribbett:

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. Iisting of devices, good nanufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820),

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Chemstrip® 5 OB, 7 and 10 MD Urine Test Strips

Indications for Use:

Multi-parameter test strips to measure certain constituents in the urine either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Chemstrip® 5 OB, 7 and 10 MD urine test strips are inert plastic strips to which are attached different reagent pads for determining specific gravity, pH, indication of leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C. Benson, Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032437

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)