S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023

K091711 · Alfa Wassermann Diagnostic Technologies, Inc. · LCP · Dec 11, 2009 · Hematology

Device Facts

• Record ID: K091711
• Device Name: S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: LCP · Hematology
• Decision Date: Dec 11, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The S-Test Hemoglobin A1c Reagent is intended for the quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

S-Test HbA1c Reagent cartridges are used with the S40 Clinical Analyzer for in vitro diagnostic determination of %HbA1c in EDTA whole blood. The system utilizes a colorimetric assay for total hemoglobin and an enzymatic assay for HbA1c. The device is intended for use in clinical laboratories or physician office laboratories (POLs) by trained personnel. The analyzer processes the sample and provides a quantitative HbA1c concentration result. Healthcare providers use this output to assess long-term glycemic control in diabetic patients, facilitating clinical decision-making regarding diabetes management.

Clinical Evidence

Performance data included precision and accuracy studies. Precision testing at three HbA1c levels over 20 days showed within-run CV of 0.9-1.1% and total CV of 1.2-1.5%. POL site precision (5 days) showed within-run CV of 0.5-1.8% and total CV of 0.7-3.2%. Accuracy was established via correlation studies with a comparative method using 110 EDTA whole blood samples (HbA1c 4.0-13.4%); results showed a correlation coefficient of 0.982. Additional POL site correlation studies yielded correlation coefficients of 0.988 to 0.996.

Technological Characteristics

Two bi-reagent cartridges. Reagents include Protease, ProClin 300, N-ethylmaleimide, N-(carboxymethyl aminocarbonyl)-4,4-bis(dimethylamino) diphenylamine sodium salt, surfactants, fructosyl peptide oxidase, peroxidase, and sodium azide (0.001%). Operates via colorimetric and enzymatic assay principles on the S40 Clinical Analyzer.

Indications for Use

Indicated for monitoring long-term glycemic control in individuals with diabetes using EDTA whole blood samples.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Predicate Devices

• Siemens Medical Systems Diagnostics DCA Vantage Test System for Hemoglobin A1c (k071466)

Submission Summary (Full Text)

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K091711

## 510(k) SUMMARY

DEC 1 1 2009

| 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: | June 8, 2009<br>(updated November 6, 2009) |
| Device: | Trade Name:<br>S-Test HbA1c Reagent cartridge<br>Classification:<br>Class II |
| | Assay, Glycosylated Hemoglobin<br>Common/Classification Name:<br>(21 C.F.R. § 864.7470), Product<br>code LCP |
| Predicate<br>Devices: | Manufacturer for analyzer/reagent system predicate:<br>Siemens Medical Solutions Diagnostics, DCA Vantage (K071466) and<br>DCA 2000+ Analyzer (K951361), Test system for Hemoglobin A1c |
| Device<br>Description: | The S-Test Hemoglobin A1c (HbA1c) reagent cartridges, used with the<br>S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic<br>determination of %HbA1c concentration in EDTA whole blood. This<br>method is based on a colorimetric assay for total hemoglobin and an<br>enzymatic assay for HbA1c. |
| Intended Use: | The S-Test Hemoglobin A1c Reagent is intended for the quantitative<br>determination of percent Hemoglobin A1c concentration in EDTA<br>whole blood using the S40 Clinical Analyzer. Measurement of<br>glycosylated hemoglobin is used for monitoring the long-term glycemic<br>control of individuals with diabetes. 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 HbA1c Reagent is contained in two bi-reagent cartridges.<br>Cartridge 1, Reagent 1 contains Protease and ProClin 300; Reagent 2<br>contains N-ethylmaleimide and ProClin 300. Cartridge 2, Reagent 1<br>contains N-(carboxymethyl aminocarbonyl)-4,4-bis(dimethylamino)<br>diphenylamine sodium salt (20 µmol/L), surfactant, ProClin 300, and<br>sodium azide (0.001%); Reagent 2 contains surfactant, fructosyl<br>peptide oxidase, and peroxidase. |
| Performance<br>Data: | Performance data on S-Test HbA1c reagent included precision and<br>accuracy data. |
| | Precision: In testing at three HbA1c levels for 20 days, the within-run<br>CV ranged from 0.9 to 1.1% and total CV ranged from 1.2 to 1.5%. In<br>precision studies at three separate Physician Office Laboratory (POL)<br>sites over five days, the within-run CV ranged from 0.5 to 1.8% and<br>total CV ranged from 0.7 to 3.2%. |
| | Accuracy: In a correlation study, 110 EDTA whole blood samples with<br>HbA1c values ranging from 4.0 to 13.4% were assayed on the S40<br>Clinical Analyzer using S-Test HbA1c (y) and a comparative method<br>(x). Least-squares regression analysis yielded a correlation coefficient<br>of 0.982, a standard error estimate of 0.39, a confidence interval slope<br>of 0.988 to 1.062, and a confidence interval intercept of -0.48 to 0.02.<br>In patient correlation studies at three separate POL sites using the S40<br>Clinical Analyzer and a comparative method, least-squares regression<br>analysis yielded correlation coefficients of 0.988 to 0.996, standard<br>error estimates of 0.18 to 0.31, confidence interval slopes of 0.957 to<br>1.065, and confidence interval intercepts of -0.64 to 0.16. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These<br>data also indicate substantial equivalence to the predicate devices. |

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a human figure, with three wavy lines emanating from the figure's head.

Alfa Wassermann Diag. Technologies, LLC c/o Dr. Hyman Katz Vice President, Ouality Assurance & Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006

k091711 Re:

> Trade Name: S-Test % Hemoglobin A1c (HbA1c) Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Codes: LCP Dated: November 24, 2009 Received: November 25, 2009

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

DEC 11 2009

Dear Dr. 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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. 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):

Device Name:

S-Test % Hemoglobin Alc (HbA)c)

Indication For Use:

The S-Test Hemoglobin Alc Reagent is intended for the quantitative determination of percent Hemoglobin Alc concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. 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)

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

Carol Benson

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

510(k) K0917