S40 CLINICAL ANALYZER, S TEST ALB

K072143 · Alfa Wassermann Diagnostic Technologies, Inc. · CIX · Jul 14, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072143
• Device Name: S40 CLINICAL ANALYZER, S TEST ALB
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: CIX · Clinical Chemistry
• Decision Date: Jul 14, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1035
• Device Class: Class 2

Intended Use

The S-Test Albumin Reagent is intended for the quantitative determination of albumin concentration in serum or heparin plasma using the S40 Clinical Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver 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 Albumin Reagent cartridge used with S40 Clinical Analyzer; performs quantitative in vitro diagnostic determination of albumin in serum or heparin plasma. Principle: photometric measurement of bluish-green complex formed by albumin and bromcresol green (BCG) at 660/700 nm. Rate of absorbance increase is proportional to albumin concentration. Used in clinical laboratories and physician office laboratories; operated by trained laboratory personnel. Cartridges are factory-calibrated with lot-specific data provided via 2D barcode. Output is quantitative albumin concentration (g/dL) used by clinicians to diagnose and monitor liver or kidney disease.

Clinical Evidence

Bench testing only. Precision studies conducted across multiple sites (in-house and three Physician Office Laboratories) using human serum pools. Method comparison performed against ACE Clinical Chemistry System (n=92 specimens, r=0.9605). Matrix comparison (serum vs. heparin plasma) showed high correlation (r=0.9944). Interference testing performed for bilirubin, lipemia, and hemolysis.

Technological Characteristics

Photometric assay using bromcresol green (BCG) reagent. Bichromatic measurement at 660/700 nm. Factory-calibrated via 2D barcode. Traceable to NIST SRM927d. Measuring range 0.4-7.1 g/dL. Compatible with S40 Clinical Analyzer. Storage 2-8°C.

Indications for Use

Indicated for quantitative determination of albumin in serum or heparin plasma for patients requiring diagnosis or treatment monitoring of liver or kidney diseases. Intended for use in clinical or physician office laboratories.

Regulatory Classification

Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

Predicate Devices

• ACE plus ISE/Clinical Chemistry System (k930104)
• Olympus AU640 Clinical Chemistry Analyzer (k924368)
• Piccolo xpress Chemistry Analyzer (k942782)

Submission Summary (Full Text)

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510(k) Summary

S40 Clinical Analyzer
S-Test ALB

### Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072143

### 510(k) SUMMARY

# JUL 1 4 2008

| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dennis Taschek<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary<br>Prepared: | July 7, 2008 |
| Device: | Trade Name: S-Test ALB (21 C.F.R. § 862.1035, Product code CIX)<br>Classification: Class II<br>Common/Classification Name: Albumin test systems |
| Predicate<br>Devices: | Manufacturers for analyzer/reagent system predicates are:<br>1. ACE plus ISE/ Clinical Chemistry System<br>ACE Albumin Reagent (K931786)<br>2. Olympus AU640 Clinical Chemistry Analyzer<br>Albumin Reagent (K961274)<br>3. Piccolo® xpress Chemistry Analyzer<br>Albumin Reagent (K942782) |
| Device<br>Description: | The S-Test albumin (ALB) reagent cartridge used with the S40 Clinical<br>Analyzer is intended for quantitative <i>in vitro</i> diagnostic determination of ALB<br>in serum or heparin plasma based on a photometric test measuring the<br>formation of a bluish-green complex from ALB and bromcresol green. |
| Intended Use: | The S-Test Albumin Reagent is intended for the quantitative determination of<br>albumin concentration in serum or heparin plasma using the S40 Clinical<br>Analyzer. Albumin measurements are used in the diagnosis and treatment of<br>numerous diseases involving primarily the liver or kidneys. This test is<br>intended for use in clinical laboratories or physician office laboratories. For <i>in<br/>vitro</i> diagnostic use only. |
| Technological<br>Characteristics: | The S-Test ALB is a bi-reagent cartridge. Reagent 1 and Reagent 2 contain:<br>bromcresol green, succinic acid buffer (pH 4.25), and nonionic surface active<br>agent. |
| Performance | Performance data on the S-Test ALB included precision, accuracy, and |
| Data: | sensitivity data. |
| | Precision: In testing conducted at three ALB levels for 22 days, the within-run<br>CV ranged from 1.8 to 2.0%, and total CV ranged from 4.7 to 5.6%. In<br>precision studies at three separate Physician Office Laboratory (POL) sites and<br>in-house over five days, the within-run CVs ranged from 0.6 to 2.5% and total<br>CVs ranged from 0.8 to 2.8%. |
| | Accuracy: In the correlation study, 92 samples with ALB values ranging from<br>0.7 to 6.8 g/dL were assayed on the S40 Clinical Analyzer using S-Test ALB<br>(y) and a comparative method (x). Least-squares regression analysis yielded a<br>correlation coefficient of 0.961, a standard error estimate of 0.24 a confidence<br>interval slope of 0.873 to 0.982, and a confidence interval intercept of 0.05 to<br>0.51. In patient correlation studies at four separate POL sites using the S40<br>Clinical Analyzer and a comparative method, least-squares regression analysis<br>yielded correlation coefficients ranged from 0.987 to 0.994, standard error<br>estimates of 0.12 to 0.19, confidence interval slopes of 0.942 to 1.040, and a<br>confidence interval intercept of -0.27 to 0.09. |
| | Sensitivity: The detection limit was 0.4 g/dL. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also<br>indicate substantial equivalence to the predicate devices. |

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Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072143

S40 Clinical Analyzer S-Test ALB

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Image /page/2/Picture/0 description: The image shows the logo and text for the Department of Health & Human Services. The logo is on the left side of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the right side of the image. The text is in all caps.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Alfa Wasserman Diagnostic Technology, Inc. c/o Mr. Dennis Taschek VP, Reagent & Instrument Technologies 4 Henderson Drive West Caldwell, NJ 07006

JUL 1 4 2008

Re: k072143

Trade Name: S-Test Albumin (ALB) Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Codes: CIX Dated: July 7, 2008 Received: July 9, 2008

Dear Mr. Taschek:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.V.M.

Séan M. Cooper, M.S., D.V.M. 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): k072143

Device Name: S-Test Albumin (ALB)

The S-Test Albumin Reagent is intended for the quantitative Indications For Use: determination of albumin concentration in serum or heparin plasma using the S40 Clinical Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver 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) .

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

Signature

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

510(k) k072143