S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017

K091544 · Alfa Wassermann, Inc. · CFJ · Sep 9, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091544
• Device Name: S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
• Applicant: Alfa Wassermann, Inc.
• Product Code: CFJ · Clinical Chemistry
• Decision Date: Sep 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1440
• Device Class: Class 2

Intended Use

The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

S-Test Lactate Dehydrogenase (LD) Reagent is a single-use cartridge system for the S40 Clinical Analyzer. Input: serum sample. Principle: kinetic enzymatic assay; LD catalyzes conversion of L-lactate to pyruvate, reducing NAD+ to NADH. Output: rate of NADH formation measured bichromatically at 340/405 nm, proportional to LD activity. Used in clinical laboratories or physician office laboratories (POLs) by trained personnel. Barcode on cartridge provides chemistry parameters and lot-specific calibration data to the analyzer. Results assist clinicians in diagnosing liver disease, myocardial infarction, and specific tumors. Benefits include rapid, quantitative assessment of LD activity for clinical decision-making.

Clinical Evidence

Bench testing only. Precision studies (22 days, three levels) showed within-run CV 1.5-2.4% and total CV 6-7.1%. POL site precision (5 days) showed within-run CV 0.9-4.3% and total CV 0.9-5.1%. Accuracy correlation studies (n=81) against a comparative method yielded a correlation coefficient of 0.9857. Additional POL site correlation studies showed correlation coefficients of 0.9971 to 0.9989. Detection limit was 9 U/L.

Technological Characteristics

Single-use plastic cartridges containing Lithium L-lactate, diethanolamine buffer, and NAD. Kinetic enzymatic assay at 37°C. Bichromatic detection at 340/405 nm. Factory calibrated via 2-D barcode. Reagent stability: 12 months at 2-8°C. Linearity: 10-672 U/L. Software: embedded firmware on S40 Clinical Analyzer.

Indications for Use

Indicated for quantitative determination of lactate dehydrogenase (LD) activity in serum to aid in diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma), cardiac diseases (e.g., myocardial infarction), and lung or kidney tumors. For use in clinical or physician office laboratories.

Regulatory Classification

Identification

A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Predicate Devices

• Alfa Wassermann ACE plus/ISE Clinical Chemistry System (k931786)

Submission Summary (Full Text)

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K091544

## SEY U 9 2009

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## 510(k) SUMMARY

| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| | Contact: | Hyman Katz, Ph.D.<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary<br>Prepared: | May 22, 2009 | |
| Device: | Trade Name: | S-Test LD Reagent cartridge |
| | Classification: | Class II Exempt |
| | Common/Classification Name: | Lactate Dehydrogenase Test<br>System<br>(21 C.F.R. § 862.1440)<br>Product Code CFJ |
| Predicate<br>Devices: | Manufacturer for analyzer/reagent system predicate:<br>Alfa Wassermann ACE plus ISE/Clinical Chemistry System<br>ACE Lactate Dehydrogenase Reagent (k931786) | |
| Device<br>Description: | The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with<br>the S40 Clinical Analyzer, is intended for the quantitative in vitro<br>diagnostic determination of LD activity in serum based on a<br>photometric test measuring the rate of conversion of NADH from NAD<br>in an enzyme assay. It is composed of a bi-reagent cartridge, and is<br>intended for use in clinical laboratories or physician office laboratories. | |
| Intended Use: | Indications for use: The S-Test Lactate Dehydrogenase Reagent is<br>intended for the quantitative determination of lactate dehydrogenase<br>activity in serum using the S40 Clinical Analyzer. Lactate<br>Dehydrogenase measurements are used in the diagnosis and treatment<br>of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic<br>carcinoma of the liver, cardiac diseases such as myocardial infarction,<br>and tumors of the lung or kidneys. This test is intended for use in<br>clinical laboratories or physician office laboratories. For in vitro<br>diagnostic use only. | |
| Technological<br>Characteristics: | The S-Test LD Reagent is contained in a bi-reagent cartridge. Reagent 1 contains: Lithium L-lactate and diethanolamine buffer. Reagent 2<br>contains: Nicotinamide adenine dinucleotide. | |
| Performance<br>Data: | Performance data on the S-Test LD included precision, accuracy, and<br>detection limit data. | |
| | Precision: In testing conducted at three LD levels for 22 days, the<br>within-run CV ranged from 1.5 to 2.4%, and total CV ranged from 6<br>to 7.1%. In precision studies at three separate Physician Office<br>Laboratory (POL) sites and in-house over 5 days, the within-run CV<br>ranged from 0.9 to 4.3% and total CV ranged from 0.9 to 5.1%. | |
| | Accuracy: In the correlation study, 81 samples with LD values ranging<br>from 26 to 652 U/L were assayed on the S40 Clinical Analyzer using S-<br>Test LD (y) and a comparative method (x). Least squares regression<br>analysis yielded a correlation coefficient of 0.9857, a standard error<br>estimate of 19.8, a confidence interval slope of 0.934 to 1.008, and a<br>confidence interval intercept of -13.3 to 2.7. In patient correlation<br>studies at four separate POL sites using the S40 Clinical Analyzer and a<br>comparative method, least-squares regression analysis yielded<br>correlation coefficients of 0.9971 to 0.9989, standard error estimates of<br>6.4 to 10.5, confidence interval slopes of 0.941 to 1.001, and a<br>confidence interval intercepts of -11.1 to 11.0. | |
| | Detection limit: The detection limit was 9 U/L. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These<br>data also indicate substantial equivalence to the predicate device. | |

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wing, and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle is positioned to the right of the text, and the text is arranged around the circumference of the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Alfa Wassermann, Inc. c/o Dr. Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006

SEP 0 9 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: k091544

Trade/Device Name: S-Test Lactate Dehydrogenase (LD), Model RC 0017 Regulation Number: 21 CFR § 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFJ Dated: July 7, 2009. Received: July 8, 2009

Dear Dr. Hyman Katz:

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.

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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

G.C.H.

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indication for Use

510(k) Number (if known): k091544

Device Name: S-Test Lactate Dehydrogenase (LD)

Indication For Use:

The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Prescription Use X (21 CFR Part 801 Subpart D) . And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

signature

Sign-Off Division Affice of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091544