S40 CLINICAL ANALYZER, S TEST IP, S TEST UA

K072141 · Alfa Wassermann Diagnostic Technologies, Inc. · CEO · Jun 24, 2008 · Clinical Chemistry

Device Facts

• Record ID: K072141
• Device Name: S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
• Applicant: Alfa Wassermann Diagnostic Technologies, Inc.
• Product Code: CEO · Clinical Chemistry
• Decision Date: Jun 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1580
• Device Class: Class 1

Intended Use

The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Story

S-Test IP and UA reagent cartridges are used with the S40 Clinical Analyzer for in vitro diagnostic testing. IP reagent uses ammonium molybdate to form molybdenum blue; UA reagent uses uricase and peroxidase to form a reddish-purple pigment. Photometric analysis of these colorimetric reactions provides quantitative concentration values. Operated by laboratory personnel in clinical or physician office settings. Output assists clinicians in diagnosing and monitoring renal, metabolic, and parathyroid conditions. Benefits include rapid, automated diagnostic assessment of patient serum or heparin plasma samples.

Clinical Evidence

Bench testing only. Precision studies (22-day and 5-day POL site studies) showed IP total CV 1.2-4.0% and UA total CV 0.7-3.5%. Accuracy correlation studies (n=95 for IP, n=183 for UA) against comparison methods yielded correlation coefficients of 0.976 (IP) and 0.974 (UA). Sensitivity (detection limits) reported as 1.2 mg/dL for IP and 1.4 mg/dL for UA.

Technological Characteristics

Single-use reagent cartridges with 2-D barcode calibration. IP reagents: p-methylaminophenol sulfate, ammonium molybdate, sulfuric acid. UA reagents: uricase, peroxidase, 4-aminoantipyrine, TOOS. Photometric sensing principle. Energy source: S40 Clinical Analyzer. Connectivity: 2-D code label for lot-specific data input. Dimensions: cartridge form factor.

Indications for Use

Indicated for quantitative determination of inorganic phosphorus and uric acid in serum or heparin plasma for patients requiring diagnosis/treatment of renal, metabolic, or parathyroid disorders, vitamin D imbalance, gout, leukemia, psoriasis, or those receiving cytotoxic drugs. Intended for use in clinical or physician office laboratories.

Regulatory Classification

Identification

A phosphorus (inorganic) test system is a device intended to measure inorganic phosphorus in serum, plasma, and urine. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance.

Predicate Devices

• ACE plus ISE/Clinical Chemistry System (k931786)
• Alfa Wassermann Piccolo xpress Chemistry Analyzer (k950164)

Submission Summary (Full Text)

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K072141

# JUN 2 4 2008

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## 510(k) SUMMARY

| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC<br>4 Henderson Drive<br>West Caldwell, NJ 07006 | |
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| Contact: | Dennis Taschek<br>Phone: [phone]<br>Fax: [phone] | |
| Date Summary Prepared: | June 19, 2008 | |
| Device: | Trade Name: | S-Test IP; S-Test UA Reagent cartridge<br>(21 C.F.R. § 862.1580, Product code CEO; 21<br>C.F.R. § 862.1775, Product code KNK |
| | Classification | Class I (reserved) |
| | Common/Classification Name: | Inorganic phosphorus; uric acid test systems |
| Predicate Devices: | | Manufacturers for analyzer/reagent system predicates are: |
| | 1. | ACE plus ISE/Clinical Chemistry System<br>ACE Inorganic Phosphorous Reagent (K931786)<br>ACE Uric Acid Reagent (K931786) |
| | 2. | Olympus AU640 Clinical Chemistry Analyzer<br>Inorganic Phosphorous Reagent (K961274)<br>Uric Acid Reagent (K961274) |
| | 3. | Piccolo® xpress Chemistry Analyzer<br>Inorganic Phosphorous Reagent (K942782)<br>Uric Acid Reagent (K942782) |
| Device Description: | | The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40<br>Clinical Analyzer, is intended for quantitative <i>in vitro</i> diagnostic determination<br>of IP in serum or heparin plasma based on a photometric test measuring the<br>formation of molybdenum blue from IP and ammonium molybdate.<br><br>The S-Test uric acid (UA) reagent cartridge, used with the S40 Clinical<br>Analyzer, is intended for quantitative <i>in vitro</i> diagnostic determination of UA<br>in serum or heparin plasma based on a photometric test measuring the<br>formation of a reddish-purple pigment. |
| Intended Use: | The S-Test Inorganic Phosphorous Reagent is intended for the quantitative<br>determination of inorganic phosphorous concentration in serum or heparin<br>plasma using the S40 Clinical Analyzer. Measurements of phosphorus<br>(inorganic) are used in the diagnosis and treatment of various disorders,<br>including parathyroid gland and kidney diseases, and vitamin D imbalance.<br>This test is intended for use in clinical laboratories or physician office<br>laboratories. For <i>in vitro</i> diagnostic use only.<br><br>The S-Test Uric Acid Reagent is intended for the quantitative determination of<br>uric acid concentration in serum or heparin plasma using the S40 Clinical<br>Analyzer. Uric acid measurements are used in the diagnosis and treatment of<br>numerous renal and metabolic disorders, including renal failure, gout,<br>leukemia, psoriasis, starvation or other wasting conditions, and of patients<br>receiving cytotoxic drugs. This test is intended for use in clinical laboratories<br>or physician office laboratories. For <i>in vitro</i> diagnostic use only. | |
| Technological<br>Characteristics: | The S-Test IP is a bi-reagent cartridge. Reagent 1 contains p-<br>methylaminophenol sulfate and nonionic surface-active agent. Reagent 2<br>contains ammonium molybdate and sulfuric acid.<br><br>The S-Test UA is a bi-reagent cartridge. Reagent 1 contains N-ethyl-N-(2-<br>hydroxy-3-sulfopropyl)-m-toluidine sodium salt (TOOS), peroxidase, and 2-<br>(N-morpholino) ethanesulfonic acid buffer (pH 6.9). Reagent 2 contains<br>uricase (derived from yeast), 4-aminoantipyrine, and 2-(N-morpholino)<br>ethanesulfonic acid buffer (pH 6.9). | |
| Performance<br>Data: | Performance data on the S-Test IP and S-Test UA included precision,<br>accuracy, and sensitivity data.<br><br><b>S-Test IP</b><br><br><b>Precision:</b> In testing conducted at three IP levels for 22 days, the within-run<br>CV ranged from 1.5 to 2.9%, and total CV ranged from 2.6 to 4.0%. In<br>precision studies at three separate Physician Office Laboratory (POL) sites and<br>in-house over five days, the within-run CV ranged from 0.9 to 3.4% and the<br>total CV ranged from 1.2 to 3.4%.<br><br><b>Accuracy:</b> In the correlation study, 95 samples with IP values ranging from<br>1.1 to 8.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test IP<br>and a comparison method. Least-squares regression analysis yielded a<br>correlation coefficient of 0.976, a standard error estimate of 0.3, a confidence<br>interval slope of 1.026 to 1.150, and a confidence interval intercept of -0.03 to<br>0.34. In patient correlation studies at three separate POL sites using the S40<br>Clinical Analyzer and a comparison method, least-squares regression analysis<br>yielded correlation coefficients ranging from 0.992 to 0.998, standard error<br>estimates of 0.10 to 0.21, confidence interval slopes of 1.002 to 1.173, and a<br>confidence interval intercept of -0.075 to 0.395.<br><br><b>Sensitivity:</b> The detection limit was 1.2 mg/dL. | |
| | S-Test UA | |
| | Precision: In testing conducted at three UA levels for 22 days, the within-run<br>CV ranged from 0.9 to 2.1%, and total CV ranged from 3.1 to 3.5%. In<br>precision studies at three separate POL sites and in-house over five days, the<br>within-run CV ranged from 0.3 to 2.2% and total CV ranged from 0.7 to 2.3%. | |
| | Accuracy: In the correlation study, 183 samples with UA values ranging from<br>2.9 to 20.2 mg/dL were assayed on the S40 Clinical Analyzer using S-Test UA<br>and a comparison method. Least-squares regression analysis yielded a<br>correlation coefficient of 0.974, a standard error estimate of 0.7, a confidence<br>interval slope of 1.003 to 1.087, and a confidence interval intercept of -1.03 to<br>-0.49. In patient correlation studies at three separate POL sites using the S40<br>Clinical Analyzer and a comparison method, least-squares regression analysis<br>yielded correlation coefficients ranging from 0.967 to 0.995, standard error<br>estimates of 0.32 to 0.69, confidence interval slopes of 0.968 to 1.202, and a<br>confidence interval intercept of -1.400 to 0.469. | |
| | Sensitivity: The detection limit was 1.4 mg/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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### JUN 2 4 2008

Alfa Wassermann Diagnostic Technologies, Inc. c/o Mr. Daivd Slavin Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006

Re: k072141

Trade/Device Name: S Test Inorganic Phosphorous (IP) Reagent cartridge and S Test Uric Acid (UA) Reagent cartridge Regulation Number: 21 CFR 862.1580 Regulation Name: Phosphorous (inorganic) test system Regulatory Class: Class I, reserved

Product Code: CEO, KNK Dated: June 18, 2008

Received: June 19, 2008

Dear Mr. Slavin

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.

Yean 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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Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072141

S40 Clinical Analyzer S-Test IP S-Test UA

#### Indications for Use

510(k) Number (if known):

K072141

S-Test Inorganic Phosphorus (IP) Devicc Name:

Indications for Use:

The S-Test Inorganic Phosphorous Reagent is intended for the quantitative determination of inorganic phosphorous concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of phosphorus (inorganic) are used in the diagnosis and treatment of various disorders, including parathyroid gland and kidney diseases, and vitamin D imbalance. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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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 (OIVD) | |
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| Division Sign-Off | |

Office of In Vitro Diagnostic CONFIDENTIA Device Evaluation and Safety

510(k) K072141

June 3, 2008

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Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072141

S40 Clinical Analyzer S-Test IP S-Test UA

#### Indications for Use

K072141 510(k) Number (if known):

Device Name: S-Test Uric Acid (UA)

Indications for Use: The S-Test Uric Acid Reagent is intended for the quantitative determination of uric acid concentration in serum or heparin plasma using the S40 Clinical Analyzer. Uric acid measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

·

Over-The-Counter Use (21 CFR 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 (OIVD)

June 3, 2008

CONFIDENTIAL