(171 days)
The S-Test Creatinine Reagent is intended for the quantitative determination of Creatinine concentration in serum or heparin plasma using the S40 Clinical Analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Creatinine (CRE) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CRE in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple pigment in a coupled enzymatic reaction.
The provided document describes the performance data for the S-Test CRE Reagent, a device for quantitative in vitro diagnostic determination of Creatinine in serum or heparin plasma.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with numerical targets. Instead, it presents performance data for precision, accuracy, and sensitivity, implying these are the metrics against which the device's performance is judged for substantial equivalence to a predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Within-run CV: Low | - In-house: 1.3 to 9.6% at three CRE levels over 22 days |
| - POL sites (3): 1.0 to 10.1% over five days | ||
| Total CV: Low | - In-house: 4.3 to 17.2% | |
| - POL sites (3): 1.3 to 10.8% | ||
| Accuracy (Correlation to Comparative Method) | Correlation Coefficient (r): High (close to 1) | - In-house: 0.998 for 65 samples (0.6 to 14.6 mg/dL) |
| - POL sites (4): 0.997 to 0.999 | ||
| Standard Error Estimate: Low | - In-house: 0.16 | |
| - POL sites (4): 0.25 to 0.34 | ||
| Confidence Interval Slope: Close to 1 (indicating proportional agreement) | - In-house: 1.002 to 1.031 | |
| - POL sites (4): 1.003 to 1.060 | ||
| Confidence Interval Intercept: Close to 0 (indicating no constant bias) | - In-house: -0.20 to -0.10 | |
| - POL sites (4): -0.38 to 0.10 | ||
| Sensitivity (Detection Limit) | Low (able to detect small amounts) | 0.3 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size:
- Precision (in-house): Not explicitly stated as a number of samples, but "three CRE levels for 22 days" implies multiple measurements at each level.
- Precision (POL): Not explicitly stated as a number of samples, but "three separate Physician Office Laboratory (POL) sites and in-house over five days" implies multiple measurements at each site.
- Accuracy (in-house correlation): 65 samples.
- Accuracy (POL correlation): Not explicitly stated as the number of samples per site, but implies multiple samples were tested at "four separate POL sites."
- Data Provenance:
- The studies were conducted in-house by Alfa Wassermann Diagnostic Technology, LLC, and at Physician Office Laboratory (POL) sites.
- The data appears to be prospective, as it describes the conduct of new studies for the purpose of demonstrating the device's performance. The nature of the "comparative method" used for accuracy also suggests a controlled test.
- The country of origin is implicitly the United States, given the submission to the FDA.
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. For an in vitro diagnostic device like Creatinine, the "ground truth" for accuracy studies is typically established by a recognized reference method or a well-established comparative method, not by individual experts or their consensus. The document explicitly states "a comparative method (x)" was used. The qualifications of the personnel operating this comparative method are not detailed.
4. Adjudication Method for the Test Set:
This information is not applicable to this type of device and study. Adjudication methods (like 2+1 or 3+1) are typically used for qualitative or subjective assessments (e.g., image interpretation) where there might be disagreement among reviewers, requiring a process to establish a consensus ground truth. For quantitative assays like Creatinine, the "truth" is derived from a measurement device (the comparative method) rather than expert opinion 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. An MRMC study is relevant for devices involving human interpretation (e.g., radiologists reading medical images). The S-Test CRE Reagent is an automated in vitro diagnostic assay for chemical analysis; it does not involve human "readers" in the context of interpretation that would be augmented by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance study was done. The entire performance data section describes the analytical performance of the S-Test CRE Reagent and S40 Clinical Analyzer system operating independently, determining Creatinine levels. There's no mention of a human "in-the-loop" influencing the results of the assay itself. The results reported (precision, accuracy, sensitivity) are inherent to the device's analytical function.
7. The Type of Ground Truth Used:
The ground truth for the accuracy studies (correlation) was established by a comparative method. The document refers to "a comparative method (x)" against which the S-Test CRE (y) was evaluated. This implies an independent, generally accepted analytical method for Creatinine measurement was used as the reference standard. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set:
This information is not provided or applicable in the context described. The S-Test CRE Reagent is a chemical assay, not an AI/ML-based algorithm that would typically require a distinct "training set" to develop. The performance studies described are for validation/testing of the established reagent formulation and analytical method.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no mention or indication of a training set as understood in the context of AI/ML or complex analytical model development. The development of a chemical reagent involves formulation and optimization, followed by validation studies against established methods to demonstrate performance. The "ground truth" for developing such a reagent would be derived from the fundamental chemical principles and established analytical standards for Creatinine measurement, not from a distinct "training set" with established ground truth labels.
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Kon0073
JUN 3 0 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 SummaryPrepared: | June 19, 2008 | ||
| Device: | Trade Name: | S-Test CRE Reagent cartridge | |
| Common/Classification Names: | Creatinine test system(21 C.F.R. § 862.1225)Product Code JFY | ||
| Classification: | Class II | ||
| PredicateDevice: | Manufacturer for analyzer/reagent system predicate is: | ||
| Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Creatinine Reagent (K931786) | |||
| DeviceDescription: | The S-Test Creatinine (CRE) reagent cartridge, used with the S40Clinical Analyzer, is intended for quantitative in vitro diagnosticdetermination of CRE in serum or heparin plasma based on aphotometric test measuring the formation of a reddish-purple pigmentin a coupled enzymatic reaction. | ||
| Intended Use: | The S-Test Creatinine Reagent is intended for the quantitativedetermination of Creatinine concentration in serum or heparin plasmausing the S40 Clinical Analyzer. Creatinine measurements are used inthe diagnosis and treatment of renal diseases, in monitoring renaldialysis, and as a calculation basis for measuring other urine analytes.This test is intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only. |
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| TechnologicalCharacteristics: | The S-Test CRE Reagent is contained in a bi-reagent cartridge.Reagent 1 contains: Creatinine amidinohydrolase, sarcosine oxidase, N-ethyl-N-sulfobutyl-m-toluidine, catalase, and N-tris (hydroxymethyl)methyl-2-aminoethane sulfonic acid (TES) buffer. Reagent 2 contains:Creatinine amidohydrolase, 4-aminoantipyrine, peroxidase, and N-tris(hydroxymethyl) methyl-2-aminoethane sulfonic acid (TES) buffer. |
|---|---|
| PerformanceData: | Performance data on the S-Test CRE Reagent included precision,accuracy, and sensitivity data.Precision: In testing at three CRE levels for 22 days, the within-runCV ranged from 1.3 to 9.6%, and total CV ranged from 4.3 to 17.2%.In precision studies at three separate Physician Office Laboratory(POL) sites and in-house over five days, the within-run CV rangedfrom 1.0 to 10.1% and total CV ranged from 1.3 to 10.8%.Accuracy: In the correlation study, 65 samples with CRE valuesranging from 0.6 to 14.6 mg/dL were assayed on the S40 ClinicalAnalyzer using S-Test CRE (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.998, astandard error estimate of 0.16, a confidence interval slope of 1.002 to1.031, and a confidence interval intercept of -0.20 to -0.10. In patientcorrelation studies at four separate POL sites using the S40 ClinicalAnalyzer and a comparative method, least-squares regression analysisyielded correlation coefficients ranged from 0.997 to 0.999, standarderror estimates of 0.25 to 0.34, confidence interval slopes of 1.003 to1.060 and a confidence interval intercepts of -0.38 to 0.10.Sensitivity: The detection limit was 0.3 mg/dL. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. Thesedata also indicate substantial equivalence to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The emblem is positioned in the center of a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircling it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alfa Wassermann Diagnostic Technology, Inc. c/o Mr. Dennis Tascheck Vice President, Reagent & Instrument Technologies 4 Henderson Drive West Caldwell, NJ 07006
JUN 3 0 2008
Re: K080073
Trade Name: S-Test Creatinine (CRE) Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine Regulatory Class: Class II Product Codes: JFY Dated: June 16, 2008 Received: June 17, 2008
Dear Mr. Tascheck:
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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Indication for Use
510(k) Number (if known): K080073
Device Name: S-Test Creatininc (CRE)
Indication For Use:
The S-Test Creatinine Reagent is intended for the quantitative determination of Creatinine concentration in serum or heparin plasma using the S40 Clinical Analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. 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 (OIVD)
spetins
Diyision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080073
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.