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 Description

The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of IP in serum or heparin plasma based on a photometric test measuring the formation of molybdenum blue from IP and ammonium molybdate.

The S-Test uric acid (UA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of UA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Alfa Wassermann S-Test IP and S-Test UA reagent cartridges, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds in a separate section. Instead, the "Performance Data" section describes the results of various tests, and the "Conclusions" section states that the device is "safe and effective" and demonstrates "substantial equivalence to the predicate devices" based on this data. I will present the reported performance data, which implicitly serves as the criteria met for acceptance.

S-Test Inorganic Phosphorus (IP) Reagent Cartridge

Performance Metric	Acceptance Criteria (Implicit from Results)	Reported Device Performance
Precision
22-day testing (within-run CV)	Low variability (e.g., CV < 5%)	1.5% to 2.9% (at 3 IP levels)
22-day testing (total CV)	Low variability (e.g., CV < 5%)	2.6% to 4.0% (at 3 IP levels)
5-day POL & in-house (within-run CV)	Low variability (e.g., CV < 5%)	0.9% to 3.4%
5-day POL & in-house (total CV)	Low variability (e.g., CV < 5%)	1.2% to 3.4%
Accuracy (Correlation to Comparison Method)	Strong correlation (e.g., r > 0.95), low error, slope near 1, intercept near 0
Main Study (Correlation Coefficient)	r > 0.95	0.976
Main Study (Std. Error Estimate)	Low error	0.3
Main Study (Confidence Interval Slope)	Encompassing 1	1.026 to 1.150
Main Study (Confidence Interval Intercept)	Encompassing 0	-0.03 to 0.34
POL Studies (Correlation Coefficient)	r > 0.95	0.992 to 0.998
POL Studies (Std. Error Estimate)	Low error	0.10 to 0.21
POL Studies (Confidence Interval Slope)	Encompassing 1	1.002 to 1.173
POL Studies (Confidence Interval Intercept)	Encompassing 0	-0.075 to 0.395
Sensitivity	Detect low concentrations (e.g., clinically relevant levels)	Detection limit: 1.2 mg/dL

S-Test Uric Acid (UA) Reagent Cartridge

Performance Metric	Acceptance Criteria (Implicit from Results)	Reported Device Performance
Precision
22-day testing (within-run CV)	Low variability (e.g., CV < 5%)	0.9% to 2.1% (at 3 UA levels)
22-day testing (total CV)	Low variability (e.g., CV < 5%)	3.1% to 3.5% (at 3 UA levels)
5-day POL & in-house (within-run CV)	Low variability (e.g., CV < 5%)	0.3% to 2.2%
5-day POL & in-house (total CV)	Low variability (e.g., CV < 5%)	0.7% to 2.3%
Accuracy (Correlation to Comparison Method)	Strong correlation (e.g., r > 0.95), low error, slope near 1, intercept near 0
Main Study (Correlation Coefficient)	r > 0.95	0.974
Main Study (Std. Error Estimate)	Low error	0.7
Main Study (Confidence Interval Slope)	Encompassing 1	1.003 to 1.087
Main Study (Confidence Interval Intercept)	Encompassing 0	-1.03 to -0.49
POL Studies (Correlation Coefficient)	r > 0.95	0.967 to 0.995
POL Studies (Std. Error Estimate)	Low error	0.32 to 0.69
POL Studies (Confidence Interval Slope)	Encompassing 1	0.968 to 1.202
POL Studies (Confidence Interval Intercept)	Encompassing 0	-1.400 to 0.469
Sensitivity	Detect low concentrations (e.g., clinically relevant levels)	Detection limit: 1.4 mg/dL

2. Sample Size Used for the Test Set and Data Provenance

S-Test IP:
- Sample Size: 95 samples for the main correlation study. "Patient correlation studies at three separate POL sites" are also mentioned, implying additional samples, but the total number for these POL studies is not explicitly stated.
- Data Provenance: Not explicitly stated, but "patient correlation studies at three separate POL sites" and "in-house" studies suggest data collected from different clinical settings and the manufacturer's laboratory, likely within the US given the context of a US FDA submission. It is reasonable to assume these were prospective or a mix of retrospective and prospective, as "patient samples" would either be freshly collected or archived. The summary does not specify.
S-Test UA:
- Sample Size: 183 samples for the main correlation study. Similar to IP, "patient correlation studies at three separate POL sites" were also conducted, with the total sample size for these not specified individually.
- Data Provenance: Similar to IP, likely from various clinical sites (POLs) and in-house, presuming US origin. The summary does not explicitly state if the data was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for these types of diagnostic tests is typically established by comparison to a recognized predicate or reference method run on a different, established analyzer (as indicated by "comparison method" in the accuracy studies) rather than human expert interpretation of raw data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as the ground truth is established through a quantitative comparison method, not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable. This is not an AI/imaging device that involves human readers or an MRMC study. It is an in vitro diagnostic device for chemical analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. This describes the performance of a reagent cartridge on a clinical analyzer, which is inherently a "standalone" measurement system for the biochemical assay it performs. There is no "algorithm" in the AI sense, nor a human-in-the-loop component for interpretation of the primary measurement.

7. The Type of Ground Truth Used

The ground truth was established by a "comparison method" using predicate or reference devices/methods. This means the results from the S-Test cartridges on the S40 Clinical Analyzer were compared against measurements from other commercially available, legally marketed diagnostic systems (e.g., ACE plus ISE/Clinical Chemistry System, Olympus AU640 Clinical Chemistry Analyzer, Piccolo® xpress Chemistry Analyzer reagents or similar) that measure inorganic phosphorus and uric acid.

8. The Sample Size for the Training Set

This information is not provided. Given that this is a traditional in vitro diagnostic device measuring chemical concentrations, there isn't a "training set" in the machine learning sense. The device's performance characteristics (precision, accuracy, sensitivity) are inherently part of its design and manufacturing process, and validated through the performance studies described, rather than "trained" on data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of this device. The reagents and analyzer are developed and manufactured to perform the specified chemical reactions, with their analytical performance validated through studies against established methods.

Summary

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K072141

JUN 2 4 2008

510(k) SUMMARY

510(k) Owner:	Alfa Wassermann Diagnostic Technology, LLC4 Henderson DriveWest Caldwell, NJ 07006
Contact:	Dennis TaschekPhone: 973-852-0177Fax: 973-852-0237
Date Summary Prepared:	June 19, 2008
Device:	Trade Name:	S-Test IP; S-Test UA Reagent cartridge(21 C.F.R. § 862.1580, Product code CEO; 21C.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 SystemACE Inorganic Phosphorous Reagent (K931786)ACE Uric Acid Reagent (K931786)
	2.	Olympus AU640 Clinical Chemistry AnalyzerInorganic Phosphorous Reagent (K961274)Uric Acid Reagent (K961274)
	3.	Piccolo® xpress Chemistry AnalyzerInorganic Phosphorous Reagent (K942782)Uric Acid Reagent (K942782)
Device Description:		The S-Test inorganic phosphorus (IP) reagent cartridge, used with the S40Clinical Analyzer, is intended for quantitative in vitro diagnostic determinationof IP in serum or heparin plasma based on a photometric test measuring theformation of molybdenum blue from IP and ammonium molybdate.The S-Test uric acid (UA) reagent cartridge, used with the S40 ClinicalAnalyzer, is intended for quantitative in vitro diagnostic determination of UAin serum or heparin plasma based on a photometric test measuring theformation of a reddish-purple pigment.
Intended Use:	The S-Test Inorganic Phosphorous Reagent is intended for the quantitativedetermination of inorganic phosphorous concentration in serum or heparinplasma 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 officelaboratories. For in vitro diagnostic use only.The S-Test Uric Acid Reagent is intended for the quantitative determination ofuric acid concentration in serum or heparin plasma using the S40 ClinicalAnalyzer. Uric acid measurements are used in the diagnosis and treatment ofnumerous renal and metabolic disorders, including renal failure, gout,leukemia, psoriasis, starvation or other wasting conditions, and of patientsreceiving cytotoxic drugs. This test is intended for use in clinical laboratoriesor physician office laboratories. For in vitro diagnostic use only.
TechnologicalCharacteristics:	The S-Test IP is a bi-reagent cartridge. Reagent 1 contains p-methylaminophenol sulfate and nonionic surface-active agent. Reagent 2contains ammonium molybdate and sulfuric acid.The S-Test UA is a bi-reagent cartridge. Reagent 1 contains N-ethyl-N-(2-hydroxy-3-sulfopropyl)-m-toluidine sodium salt (TOOS), peroxidase, and 2-(N-morpholino) ethanesulfonic acid buffer (pH 6.9). Reagent 2 containsuricase (derived from yeast), 4-aminoantipyrine, and 2-(N-morpholino)ethanesulfonic acid buffer (pH 6.9).
PerformanceData:	Performance data on the S-Test IP and S-Test UA included precision,accuracy, and sensitivity data.S-Test IPPrecision: In testing conducted at three IP levels for 22 days, the within-runCV ranged from 1.5 to 2.9%, and total CV ranged from 2.6 to 4.0%. Inprecision studies at three separate Physician Office Laboratory (POL) sites andin-house over five days, the within-run CV ranged from 0.9 to 3.4% and thetotal CV ranged from 1.2 to 3.4%.Accuracy: In the correlation study, 95 samples with IP values ranging from1.1 to 8.9 mg/dL were assayed on the S40 Clinical Analyzer using S-Test IPand a comparison method. Least-squares regression analysis yielded acorrelation coefficient of 0.976, a standard error estimate of 0.3, a confidenceinterval slope of 1.026 to 1.150, and a confidence interval intercept of -0.03 to0.34. In patient correlation studies at three separate POL sites using the S40Clinical Analyzer and a comparison method, least-squares regression analysisyielded correlation coefficients ranging from 0.992 to 0.998, standard errorestimates of 0.10 to 0.21, confidence interval slopes of 1.002 to 1.173, and aconfidence interval intercept of -0.075 to 0.395.Sensitivity: The detection limit was 1.2 mg/dL.
	S-Test UA
	Precision: In testing conducted at three UA levels for 22 days, the within-runCV ranged from 0.9 to 2.1%, and total CV ranged from 3.1 to 3.5%. Inprecision studies at three separate POL sites and in-house over five days, thewithin-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 from2.9 to 20.2 mg/dL were assayed on the S40 Clinical Analyzer using S-Test UAand a comparison method. Least-squares regression analysis yielded acorrelation coefficient of 0.974, a standard error estimate of 0.7, a confidenceinterval slope of 1.003 to 1.087, and a confidence interval intercept of -1.03 to-0.49. In patient correlation studies at three separate POL sites using the S40Clinical Analyzer and a comparison method, least-squares regression analysisyielded correlation coefficients ranging from 0.967 to 0.995, standard errorestimates of 0.32 to 0.69, confidence interval slopes of 0.968 to 1.202, and aconfidence 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 alsoindicate 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 (240) 276-0490. 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 (800) 638-2041 or (240) 276-3150 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:

Prescription Use X (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)
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

Regulation Number and Section

§ 862.1580 Phosphorus (inorganic) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.