(105 days)
The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used with the S40 Clinical Analyzer, is intended for the quantitative in vitro diagnostic determination of LD activity in serum based on a photometric test measuring the rate of conversion of NADH from NAD in an enzyme assay. It is composed of a bi-reagent cartridge, and is intended for use in clinical laboratories or physician office laboratories.
The S-Test LD Reagent cartridge is intended for the quantitative in vitro diagnostic determination of LD activity in serum, used with the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases (e.g., acute viral hepatitis, cirrhosis, metastatic carcinoma of the liver), cardiac diseases (e.g., myocardial infarction), and tumors of the lung or kidneys.
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
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Precision | Within-run CV: Low (e.g., <5-10%)Total CV: Low (e.g., <10-15%) | In-house (3 LD levels, 22 days):- Within-run CV: 1.5% to 2.4%- Total CV: 6% to 7.1%POL sites (3 sites, 5 days):- Within-run CV: 0.9% to 4.3%- Total CV: 0.9% to 5.1% |
| Accuracy (Correlation to Comparative Method) | Correlation Coefficient (r): High (e.g., >0.95)Slope: Close to 1.0Intercept: Close to 0 | In-house (81 samples, 26 to 652 U/L):- Correlation coefficient: 0.9857- Standard error estimate: 19.8- Confidence interval slope: 0.934 to 1.008- Confidence interval intercept: -13.3 to 2.7POL sites (4 sites):- Correlation coefficients: 0.9971 to 0.9989- Standard error estimates: 6.4 to 10.5- Confidence interval slopes: 0.941 to 1.001- Confidence interval intercepts: -11.1 to 11.0 |
| Detection Limit | Low (e.g., clinically relevant lower bound) | 9 U/L |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy Study (In-house): 81 samples
- Sample Size for Accuracy Studies (POL sites): Not explicitly stated, but implies multiple samples were tested at each of the four separate POL sites.
- Sample Size for Precision Study (In-house): Not explicitly stated how many individual measurements contributed to the CVs, but involved testing at three LD levels over 22 days.
- Sample Size for Precision Study (POL sites): Not explicitly stated, but involved testing at three separate POL sites over 5 days.
- Data Provenance: The studies were conducted "in-house" (presumably by Alfa Wassermann Diagnostic Technologies, LLC, in the US) and at "three separate Physician Office Laboratory (POL) sites" and "four separate POL sites," indicating that data was collected from various clinical settings. Given the submitter's location in New Jersey, USA, and the FDA submission, it's highly probable the data is from the United States. The studies appear to be prospective as performance specific to this device and its use with the S40 Clinical Analyzer was generated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic (IVD) device for quantitative biochemical measurement. The "ground truth" for the test set is established by a comparative, legally marketed method (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent), not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD device measuring a biochemical marker against a comparative method, there is no human adjudication involved in establishing the "ground truth." The comparison is a direct numerical correlation between the S-Test LD and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an in vitro diagnostic test for quantitative determination of an analyte (LD activity). MRMC studies are typically performed for diagnostic imaging or pathology devices where human readers interpret medical images or samples.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this describes the primary performance evaluation. The S-Test LD Reagent cartridge, when used with the S40 Clinical Analyzer, performs the quantitative measurement of LD activity without human interpretation in the results generation. The performance data presented (precision, accuracy, detection limit) are direct technical performance characteristics of the device itself.
7. Type of Ground Truth Used
The ground truth for the performance studies was established by comparison to a legally marketed predicate device (Alfa Wassermann ACE plus ISE/Clinical Chemistry System ACE Lactate Dehydrogenase Reagent) using the "comparative method." This is a common and accepted method for establishing the performance equivalence of new IVD assays.
8. Sample Size for the Training Set
Not applicable. This is a biochemical reagent and analyzer system, not a machine learning or AI-based device that requires a "training set" in the conventional sense of artificial intelligence. The device's operational parameters and calibration procedures are established through manufacturing and quality control, not through a data training pipeline.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As mentioned above, there is no "training set" for this type of IVD device in the context of machine learning. The operational characteristics and performance specifications are inherent to the chemical reactions and instrumental design, validated through standard analytical performance studies.
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SEY U 9 2009
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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 22, 2009 | |
| Device: | Trade Name: | S-Test LD Reagent cartridge |
| Classification: | Class II Exempt | |
| Common/Classification Name: | Lactate Dehydrogenase TestSystem(21 C.F.R. § 862.1440)Product Code CFJ | |
| PredicateDevices: | Manufacturer for analyzer/reagent system predicate:Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Lactate Dehydrogenase Reagent (K931786) | |
| DeviceDescription: | The S-Test Lactate Dehydrogenase (LD) reagent cartridge, used withthe S40 Clinical Analyzer, is intended for the quantitative in vitrodiagnostic determination of LD activity in serum based on aphotometric test measuring the rate of conversion of NADH from NADin an enzyme assay. It is composed of a bi-reagent cartridge, and isintended for use in clinical laboratories or physician office laboratories. | |
| Intended Use: | Indications for use: The S-Test Lactate Dehydrogenase Reagent isintended for the quantitative determination of lactate dehydrogenaseactivity in serum using the S40 Clinical Analyzer. LactateDehydrogenase measurements are used in the diagnosis and treatmentof liver diseases such as acute viral hepatitis, cirrhosis, and metastaticcarcinoma of the liver, cardiac diseases such as myocardial infarction,and tumors of the lung or kidneys. This test is intended for use inclinical laboratories or physician office laboratories. For in vitrodiagnostic use only. | |
| TechnologicalCharacteristics: | The S-Test LD Reagent is contained in a bi-reagent cartridge. Reagent 1 contains: Lithium L-lactate and diethanolamine buffer. Reagent 2contains: Nicotinamide adenine dinucleotide. | |
| PerformanceData: | Performance data on the S-Test LD included precision, accuracy, anddetection limit data. | |
| Precision: In testing conducted at three LD levels for 22 days, thewithin-run CV ranged from 1.5 to 2.4%, and total CV ranged from 6to 7.1%. In precision studies at three separate Physician OfficeLaboratory (POL) sites and in-house over 5 days, the within-run CVranged from 0.9 to 4.3% and total CV ranged from 0.9 to 5.1%. | ||
| Accuracy: In the correlation study, 81 samples with LD values rangingfrom 26 to 652 U/L were assayed on the S40 Clinical Analyzer using S-Test LD (y) and a comparative method (x). Least squares regressionanalysis yielded a correlation coefficient of 0.9857, a standard errorestimate of 19.8, a confidence interval slope of 0.934 to 1.008, and aconfidence interval intercept of -13.3 to 2.7. In patient correlationstudies at four separate POL sites using the S40 Clinical Analyzer and acomparative method, least-squares regression analysis yieldedcorrelation coefficients of 0.9971 to 0.9989, standard error estimates of6.4 to 10.5, confidence interval slopes of 0.941 to 1.001, and aconfidence interval intercepts of -11.1 to 11.0. | ||
| Detection limit: The detection limit was 9 U/L. | ||
| 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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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 stylized eagle with three lines forming its body and wing, and a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The eagle is positioned to the right of the text, and the text is arranged around the circumference of the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Alfa Wassermann, Inc. c/o Dr. Hyman Katz 4 Henderson Drive West Caldwell, NJ 07006
SEP 0 9 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K091544
Trade/Device Name: S-Test Lactate Dehydrogenase (LD), Model RC 0017 Regulation Number: 21 CFR § 862.1440 Regulation Name: Lactate dehydrogenase test system Regulatory Class: Class II Product Code: CFJ Dated: July 7, 2009. Received: July 8, 2009
Dear Dr. Hyman 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 of medical devicerelated 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/Resourcesfor You/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): K091544
Device Name: S-Test Lactate Dehydrogenase (LD)
Indication For Use:
The S-Test Lactate Dehydrogenase Reagent is intended for the quantitative determination of lactate dehydrogenase activity in serum using the S40 Clinical Analyzer. Lactate Dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung 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)
(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 (OVD)
signature
Sign-Off Division Affice of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091544
§ 862.1440 Lactate dehydrogenase test system.
(a)
Identification. A lactate dehydrogenase test system is a device intended to measure the activity of the enzyme lactate dehydrogenase in serum. Lactate dehydrogenase measurements are used in the diagnosis and treatment of liver diseases such as acute viral hepatitis, cirrhosis, and metastatic carcinoma of the liver, cardiac diseases such as myocardial infarction, and tumors of the lung or kidneys.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.