QUANTIFY(901)

K972710 · Hematronix, Inc. · JJW · Aug 15, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972710
• Device Name: QUANTIFY(901)
• Applicant: Hematronix, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Aug 15, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The Hematronix qUAntify™ Control System is a liquid, ready-touse, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals. Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick Alternative tests such as the Glucose (Clinites), testing. Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.

Device Story

qUAntify is a liquid, ready-to-use urine dipstick control system; requires no reconstitution or dilution. Prepared from human source material and predetermined chemicals. Used in clinical laboratory settings to evaluate day-to-day test performance; monitors accuracy and precision of semiquantitative urine dipstick tests (e.g., specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, hemoglobin, hCG). Two distinct levels (normal and abnormal) verify recovery of patient values. Healthcare providers use control results to validate instrument performance and ensure reliable patient testing. Contains sodium azide (0.05%) and human blood products; donors screened for HIV, HCV, and HBsAg.

Clinical Evidence

Bench testing only. Evaluated on multiple instruments for 11 analytes (specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, hemoglobin, hCG). Performance compared to Kenlor Liquid Urine Control package insert ranges. Results demonstrated substantial equivalence in precision and recovery for both normal and abnormal levels.

Technological Characteristics

Liquid, ready-to-use urine control. Matrix: human source materials and predetermined chemicals. Contains 0.05% sodium azide. Stability: 2 years at 2-8°C (unopened), 30 days at room temp (opened). No software or electronic components.

Indications for Use

Indicated for use as a quality control material to monitor the accuracy and precision of semiquantitative urine dipstick testing, including specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, hemoglobin, and hCG tests. Intended for laboratory use to verify recovery of normal and elevated values.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Kenlor Liquid Urine Control (K890577)

Submission Summary (Full Text)

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K972710

### AUG 1 5 1997

Page Al of A3

### 510(k) Summary

For any questions contact: James D. Lapicola 524 Stone Road Benicia, CA 94510 [phone] ext 208 FAX: [phone]

Date Prepared: July 18, 1997

#### Gentlemen:

Following is a summary of the basis for a substantially equivalent determination:

| Hematronix Product | |
|---------------------|-----------------------------------------------|
| Trade Name | qUAntify |
| Common Name | Clinical Chemistry<br>Urine Control |
| Classification Name | Quality Control Material<br>per 21CFR862.1660 |

Substantially Equivalent Device: Kenlor Liquid Ürine 510 ( k ) Control see #K890577

- is currently "manufactured for" Please note: qUAntify HEMATRONIX, INC. by Kenlor Industries. It is intention to manufacture the material our ourselves.
### Device Description/INTENDED USE

The Hematronix qUAntify™ Control System is a liquid, ready-touse, urine dipstick control. No reconstitution or dilution is required. The control is prepared from human source material and predetermined chemicals.

Controls evaluate the quality of day-to-day test performance. The qUAntify Control System is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick Alternative tests such as the Glucose (Clinites), testing. Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified urine hCG tests. Two distinct levels are included to verify the recovery of normal and elevated patient values.

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I

# Technological Characteristic Comparison

Both Kenlor's Liquid Urine Control and Hematronix' qUAntify are prepared from human source materials and predetermined chemicals. Two distinct levels are provided to verify the recovery of normal and elevated patient values.

Equivalency between qUAntify and Kenlor Liquid Urine Control

| | qUAntify<br>(Applicant) | Liquid Urine Control<br>(Kenlor) |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | To monitor the:<br>precision system<br>for the analytes<br>listed. | To monitor the<br>precision system<br>for the analytes<br>listed. |
| Measurement<br>Technique: | Semiquantitative<br>testing and assays | Semiquantitative<br>testing and assays |
| Analytes: | Specific Gravity<br>pH<br>Leukocytes<br>Nitrite<br>Protein<br>Glucose<br>Ketones<br>Urobilinogen<br>Bilirubin<br>Hemoglobin<br>HCG | Specific Gravity<br>pH<br>Leukocytes<br>Nitrite<br>Protein<br>Glucose<br>Ketones<br>Urobilinogen<br>Bilirubin<br>Hemoglobin<br>HCG |
| Number of<br>Common Analytes: | 11 | 11 |
| Matrix: | Human Source Materials<br>and predetermined<br>chemicals | Human Source Materials<br>and predetermined<br>chemicals |
| Stability: | Unopened Vial<br>2 years at 2°-8°C<br><br>Opened Vial<br>30 days at room temp. | Unopened Vial<br>2 years at 2°-8°C<br><br>Opened Vial<br>30 days at room temp. |

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## Non Clinical Performance Data - Conclusions

qUAntify was evaluated on several instruments for all 11 The ranges observed were compared to published analytes. analy of the same analytes in package inserts provided with Kenlor's Liquid Urine Control. The ranges were substantially The data is summmaried in the following table. equivalent.

| qUAntify<br>mfg by HEMATRONIX, INC. | Liquid Urine Control<br>mfg by Kenlor | |
|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Level I (Normal): | | |
| Specific Gravity<br>pH | 1.020 ±.005<br>6 ±.5 | 1.010 ±.005<br>5.5 ±.5 |
| Level II (Abnormal): | | |
| Specific Gravity<br>pH<br>Leukocytes<br>Nitrite<br>Protein<br>Glucose<br>Ketones<br>Urobilinogen<br>Bilirubin<br>Hemoglobin<br>HCG | 1.010-1.015<br>8<br>++<br>+<br>100<br>250-500<br>++<br>1-8<br>++<br>250<br>+ | 1.005-1.015<br>7-8<br>+<br>+<br>100<br>250-350<br>++<br>1-4<br>+++<br>250<br>+ |

Equivalency Ranges as measures of Precision.

## Safety and Effectiveness Conclusions:

- qUAntify and Kenlor's MSDS list: 1) sodium azide Safety acts as a constituent (0.05%); and 2) Human blood blood products which is potentially and a biohazardous material. Each blood donor, however, is tested by FDA approved methods for HIV, HCV and HBs Aq.
- As seen in the Non Clinical Performance Effectiveness -Data section above, the qUAntify control system will evaluate the guality of dayto-day test performance when used to determine accuracy and precision in the measurement of the physical and chemical commonly employed in semitests quantitative urine dipstick testing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James D. Lapicola Executive Vice President Hematronix, Inc. 524 Stone Road Benicia, CA 94510

AUG 1 5 1997

K972710 Re : qUAntify Requlatory Class: I Product Code: JJW Dated: July 18, 1997 Received: July 21, 1997

Dear Mr. Lapicola:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to the regulation Chercrea, "Miobranding by rolusios of the general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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:10(k) Number (if known):

)evice Name: qUAntify

ndications For Use:

The Hematronix qUAntify TM Control System is a liquid, ready-to-use urine dipstick No reconstitution or dilution is required. The control is prepared from control. numan source material and predetermined chemicals.

jontrols evaluate the quality of day-to-day test performance. The qUAntify Control ystem is used to determine accuracy and precision in the measurement of the physical and chemical tests commonly employed in semiquantitative urine dipstick testing. Ilternative tests such as the Glucose (Clinites), Bilirubin (Ictotest) and Ketone (Acetest) are also assayed. This control can be used to quality control the specified rine hCG tests. Two distinct levels are included to verify the recovery of normal nd elevated patient values.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

-Off)
Clinical Laboratory Devices
Number K972710

escription Use er 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)