(89 days)
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of LDL cholesterol concentrations in serum or heparin plasma based on a photometric test measuring the formation of a reddish purple complex in a coupled enzymatic reaction.
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance (S-Test LDL reagent with S40 Clinical Analyzer) |
|---|---|---|
| Precision | Not explicitly stated, but generally indicative of good clinical practice for quantitative assays. | Within-run CV: 1.2 to 2.2% (at three LDL levels over 22 days); 0.8 to 2.8% (at three POL sites over 5 days) |
| Total CV: 2.2 to 2.5% (at three LDL levels over 22 days); 1.2 to 2.8% (at three POL sites over 5 days) | ||
| Accuracy (Correlation to Comparative Method) | Not explicitly stated, but generally high correlation (e.g., R-value > 0.95) with acceptable bias and confidence intervals for slopes and intercepts are expected. | Correlation Coefficient: 0.996 (for 110 serum samples, 11-388 mg/dL) |
| Standard Error Estimate: 6.6 | ||
| Confidence Interval Slope: 0.948 to 0.982 | ||
| Confidence Interval Intercept: -1.7 to 3.4 | ||
| POL Site Correlations: 0.995 to 0.997 (correlation coefficients); 6.0 to 8.0 (standard error estimates); 0.895 to 0.967 (confidence interval slopes); -4.6 to 13.6 (confidence interval intercepts) | ||
| Sensitivity (Detection Limit) | Not explicitly stated, but a low detection limit is desirable for clinical utility, especially for lower values. | 1 mg/dL |
| Matrix Comparison (Serum vs. Plasma) | Not explicitly stated, but no statistically significant difference between serum and heparin plasma measurements is expected to demonstrate interchangeable use. | t-Statistic: 1.71 (for 34 paired samples, 13-350 mg/dL) |
| t-Critical Value: 2.03 at α = 0.05 | ||
| Conclusion: Not statistically significant difference between serum and plasma, confirming use of plasma. |
2. Sample Size and Data Provenance for the Test Set:
- Precision Studies:
- Main Study: Not explicitly stated, but "three LDL levels for 22 days" implies repeated measurements over time. The number of individual samples for within-run and total CV calculation would be based on these repeated measurements at each level.
- POL Site Studies: "three separate Physician Office Laboratory (POL) sites over 5 days" at "three separate POL sites." Similar to the main study, number of individual samples would be based on repeated measurements at each POL site.
- Accuracy (Correlation Study): 110 serum samples with LDL values ranging from 11 to 388 mg/dL.
- Matrix Comparison (Serum vs. Plasma): 34 paired samples drawn from the same patients.
- Data Provenance: The document does not explicitly state the country of origin for the data. Given the submission is to the FDA, it is likely the studies were conducted in the US or in a manner compliant with US regulatory standards. The studies appear to be prospective in nature, as they involve performing tests on samples to evaluate device performance.
3. Number of Experts and Qualifications for Ground Truth:
The document describes performance studies comparing the S-Test LDL reagent to a "comparative method" or a "predicate device" (Alfa Wassermann ACE plus ISE/Clinical Chemistry System with ACE Low Density Lipoprotein Cholesterol Reagent K991733).
- Number of Experts: Not applicable. The ground truth for this type of IVD device is typically established by another established, validated reference method or device, rather than by human expert consensus or interpretation of images.
- Qualifications of Experts: Not applicable. The "ground truth" is analytical results from an established comparative method or predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The reported studies are analytical performance studies for an in vitro diagnostic (IVD) device, not studies involving human interpretation or adjudication. The "adjudication" is essentially the direct comparison of quantitative results between the candidate device and a comparative method using statistical analysis (e.g., least-squares regression, t-test).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human readers interpret outputs (e.g., medical images). The S-Test LDL Cholesterol Reagent is an automated in vitro diagnostic assay that provides a quantitative numerical result, not an image or output requiring human interpretation in the context of a "reader."
6. Standalone (Algorithm Only) Performance:
Yes, the studies described are standalone performance studies of the S-Test LDL Reagent used with the S40 Clinical Analyzer. The purpose is to demonstrate the analytical performance of the device itself (reagent and analyzer system) without human diagnostic interpretation being a variable in the performance assessment.
7. Type of Ground Truth Used:
The ground truth used was analytical measurements obtained from a comparative method or predicate device. This is a common approach for establishing the accuracy of new in vitro diagnostic assays by correlating their results with those of an already accepted and validated method.
8. Sample Size for the Training Set:
The document does not provide information on a "training set" in the context of machine learning or AI models. This device is a traditional in vitro diagnostic reagent and analyzer system, not an AI-powered device that requires training data. The studies described are for analytical validation.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or AI model development in the provided text.
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AUG Ó 3 2009
Attachment 2 – 510(k) Summary
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006 | |
|---|---|---|
| Contact: | Hyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237 | |
| Date SummaryPrepared: | May 5, 2009 | |
| Device: | Trade Name: | S-Test LDL Reagent cartridge |
| Classification: | Class I Exempt | |
| Common/Classification Name: | Low Density Lipoprotein Cholesterol TestSystem(21 C.F.R. § 862.1475)Product Code MRR | |
| PredicateDevices: | Manufacturer for analyzer/reagent system predicate:Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Low Density Lipoprotein Cholesterol Reagent (K991733) | |
| DeviceDescription: | The S-Test Low Density Lipoprotein (LDL) Cholesterol reagent cartridges,used with the S40 Clinical Analyzer, are intended for quantitative in vitrodiagnostic determination of LDL cholesterol concentrations in serum orheparin plasma based on a photometric test measuring the formation of areddish purple complex in a coupled enzymatic reaction. | |
| Intended Use: | The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for thequantitative determination of LDL concentration in serum or heparin plasmausing the S40 Clinical Analyzer. Lipoprotein measurements are used in thediagnosis and treatment of lipid disorders (such as diabetes mellitus),atherosclerosis, and various liver and renal diseases. This test is intended foruse in clinical laboratories or physician office laboratories. For in vitrodiagnostic use only. | |
| TechnologicalCharacteristics: | The S-Test LDL Reagent is contained in a bi-reagent cartridge. Reagent 1contains 4-aminoantipyrine, cholesterol esterase, cholesterol oxidase,peroxidase, and a surfactant in Good's buffer. Reagent 2 contains a differentsurfactant, N,N-bis (4-sulfobutyl)-m-toluidine, disodium salt in Good's buffer. | |
| PerformanceData: | Performance data on the S-Test LDL reagent included precision, accuracy,sensitivity data and matrix comparison data. | |
| Precision: In testing at three LDL levels for 22 days, the within-run CVranged from 1.2 to 2.2%, and total CV ranged from 2.2 to 2.5%. In precisionstudies at three separate Physician Office Laboratory (POL) sites over 5 days,the within-run CV ranged from 0.8 to 2.8% and total CV ranged from 1.2 to2.8%. | ||
| Accuracy: In a correlation study, 110 serum samples with LDL values rangingfrom 11 to 388 mg/dL were assayed on the S40 Clinical Analyzer using S-Test LDL (y) and a comparative method (x). Least-squares regression analysisyielded a correlation coefficient of 0.996, a standard error estimate of 6.6, aconfidence interval slope of 0.948 to 0.982, and a confidence interval interceptof -1.7 to 3.4. In patient correlation studies at three separate POL sites usingthe S40 Clinical Analyzer and a comparative method, least-squares regressionanalysis yielded correlation coefficients of 0.995 to 0.997, standard errorestimates of 6.0 to 8.0, confidence interval slopes of 0.895 to 0.967, andconfidence interval intercepts of -4.6 to 13.6. | ||
| Sensitivity: The detection limit was 1 mg/dL. | ||
| Serum vs. Plasma: A study was performed by running LDL determinations on34 paired samples drawn from the same patients in serum and lithium heparinplasma tubes. The use of plasma was confirmed in a matrix comparison studyusing the paired t-test for means: Range: 13 to 350 mg/dL (serum), t-Statistic= 1.71, t-Critical value 2.03 at a = 0.05, not statistically significant. | ||
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data alsoindicate substantial equivalence to the predicate device. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized wing shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Alfa Wasserman, Inc. c/o Mr. Hyman Katz Vice President, Quality & Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
AUG 0 3 2009
Re: K091333
Trade Name: S-Test LDL Cholesterol (LDL) Regulation Number: 21 CFR $862.1475 Regulation Name: Lipoprotein test system. Regulatory Class: Class I Product Codes: MRR Dated: May 5, 2009 Received: May 6, 2009
Dear Mr. 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 (OS) 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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
G.C.H
Courtney C. Harper, Ph.D. Acting 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): K091333
Device Name:
S-Test Low Density Lipoprotein (LDL) Cholesterol
Indication For Use:
The S-Test Low Density Lipoprotein Cholesterol Reagent is intended for the quantitative determination of LDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. 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) Over the Counter Use -(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091333
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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 § 862.9.