(42 days)
The S-Test Creatine Kinase Reagent is intended for the quantitative determination of Creatine Kinase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of creatine phosphokinase activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Creatine Kinase (CK) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CK activity in serum or heparin plasma based on a photometric test measuring the formation of NADPH, which absorbs strongly at 340 nm.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Consistent and low variability in results (low CV%) for different CK levels. | In-house (22 days):- Within-run CV: 1.4% to 2.0% (at three CK levels)- Total CV: 5.1% to 6.1%Field (3 POL sites, 5 days):- Within-run CVs: 0.5% to 3.7%- Total CVs: 0.8% to 3.7% |
| Accuracy | High correlation with a comparative method (high correlation coefficient, slope near 1, intercept near 0, low standard error). | Correlation Study (95 samples, CK: 32-1181 U/L):- Correlation coefficient (r): 0.998- Standard error estimate: 14.5- Confidence interval slope: 1.027 to 1.053- Confidence interval intercept: -12.5 to -5.2Patient Correlation Studies (3 POL sites):- Correlation coefficients (r): 1.00- Standard error estimates: 5.0 to 8.5- Confidence interval slopes: 1.006 to 1.059- Confidence interval intercepts: -10.8 to -3.5 |
| Sensitivity | Ability to detect low levels of CK activity. | The detection limit was 24 U/L. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Precision:
- In-house: Not explicitly stated, but "three CK levels for 22 days" implies a substantial number of replicates per level.
- Field: Not explicitly stated, but "three separate Physician Office Laboratory (POL) sites and in-house over five days" implies multiple replicates per site and day.
- Accuracy (Correlation Study): 95 samples with CK values ranging from 32 to 1181 U/L.
- Accuracy (Patient Correlation Studies): Not explicitly stated, but performed at "three separate POL sites."
- Sensitivity: Not explicitly stated, but the "detection limit" is a single value derived from testing.
- Precision:
- Data Provenance: The document does not explicitly state the country of origin. The test for precision was conducted both in-house and at three Physician Office Laboratory (POL) sites. The accuracy studies were also conducted in a similar fashion. It is implied to be a prospective study as this is performance data reported for submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (Clinical Analyzer for Creatine Kinase) does not typically involve human experts establishing a "ground truth" for the test set in the same way an imaging or diagnostic AI device does. The ground truth for such devices is established by a "comparative method" (a reference laboratory method or an established, legally marketed device against which the new device's performance is measured).
Therefore:
- Number of Experts: Not applicable in the context of typical AI device ground truth.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
Not applicable. For a clinical analyzer, the "ground truth" is determined by a comparative laboratory method, not by human expert adjudication of individual case results.
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 imaging or diagnostic AI devices where human readers interpret results, and the AI might assist in that interpretation. The S-Test CK is a clinical analyzer for quantitative determination of an analyte, not an AI-assisted diagnostic tool that humans interpret visually.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the studies described are standalone performance evaluations of the S-Test CK reagent and S40 Clinical Analyzer system. The device itself performs the quantitative measurement of CK activity. There is no human interpretation "in the loop" that would alter the device's numerical output for the specified performance metrics.
7. Type of Ground Truth Used
The ground truth for the accuracy studies was established by a comparative method. This refers to an established, presumably FDA-cleared or gold-standard laboratory assay for creatine kinase. The document states: "assayed on the S40 Clinical Analyzer using S-Test CK (y) and a comparative method (x)."
8. Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning. This device is a traditional in-vitro diagnostic (IVD) measurement system, not a machine learning or AI-based device that requires a separate training set for algorithm development. The "training" for such devices typically refers to the development and optimization of the chemical reagents and instrument calibration, which is not usually reported with specific sample sizes in this manner.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, this is not an AI/ML device requiring a training set with established ground truth. The "ground truth" related to the performance of the system would be established through internal R&D and validation processes using reference materials and comparative methods, but this is part of the product development rather than a labeled "training set" for an algorithm.
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510(k) Submission S40 Clinical Analyzer
S-Test CK
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC4 Henderson DriveWest Caldwell, NJ 07006 | SEP 1 8 2008 |
|---|---|---|
| Contact: | Dennis TaschekPhone: 973-852-0177Fax: 973-852-0237 | K082226 |
| Date Summary Prepared: | July 14, 2008 | |
| Device: | ||
| Trade Names: S-Test CK Reagent cartridge | ||
| Classification: Class II | ||
| Common/Classification Name: CK: Creatine phosphokinase/creatinekinase or isoenzymes test system(21 C.F.R. § 862.1215)Product Code JHS | ||
| Predicate Device: | Manufacturer for analyzer/reagent system predicate is: | |
| Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemACE Creatine Kinase Reagent (K931786) | ||
| Device Description: | The S-Test Creatine Kinase (CK) reagent cartridge, used with the S40 ClinicalAnalyzer, is intended for quantitative in vitro diagnostic determination of CKactivity in serum or heparin plasma based on a photometric test measuring theformation of NADPH, which absorbs strongly at 340 nm. | |
| Intended Use: | The S-Test Creatine Kinase Reagent is intended for the quantitativedetermination of Creatine Kinase activity in serum or heparin plasma using theS40 Clinical Analyzer. Measurements of creatine phosphokinase activity areused in the diagnosis and treatment of myocardial infarction and musclediseases such as progressive, Duchenne-type muscular dystrophy. This test isintended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only. | |
| Technological Characteristics: | The S-Test CK Reagent is contained in a bi-reagent cartridge. Reagent 1contains: Hexokinase, glucose-6-phosphate dehydrogenase, adenosine-5'-diphosphoric acid, D-glucose, and nicotinamide adenine dinucleotide phosphate(oxidized form). Reagent 2 contains: Creatine phosphate. |
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Performance data on the S-Test CK reagent included precision, accuracy, and Performance sensitivity data. Data:
Precision: In testing at three CK levels for 22 days, the within-run CV ranged from 1.4 to 2.0%, and total CV ranged from 5.1 to 6.1%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CVs ranged from 0.5 to 3.7% and total CVs ranged from 0.8 to 3.7%.
Accuracy: In a correlation study, 95 samples with CK values ranging from 32 to 1181 U/L were assayed on the S40 Clinical Analyzer using S-Test CK (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.998, a standard error estimate of 14.5, a confidence interval slope of 1.027 to 1.053, and a confidence interval intercept of -12.5 to -5.2. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 1.00, standard error estimates of 5.0 to 8.5, confidence interval slopes of 1.006 to 1.059, and a confidence interval intercepts of -10.8 to -3.5.
Sensitivity: The detection limit was 24 U/L.
Based on the foregoing data, the device is safe and effective. These data also Conclusions: indicate substantial equivalence to the predicate device.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is black and the background is white. The text is centered in the image.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alfa Wassermann Diagnostic Technologies, Inc. c/o Mr. Dennis Taschek Vice President, Reagent and Instrument Technology 4 Henderson Drive West Caldwell, NJ 07006
SEP 1 8 2008
Re: K082226
Trade/Device Name: S-Test CK Reagent Cartridge Regulation Number: 21 CFR 862.1215 Regulation Namc: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHS Dated: August 14, 2008 Received: August 18, 2008
Dear Mr. Taschek:
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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Page 2 -
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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510(k) Submission S40 Clinical Analyzer S-Test CK
Indications for Use
510(k) Number (if known):
Device Name: . S-Test Creatine Kinase (CK)
Indications for Use: The S-Test Creatine Kinase Reagent is intended for the quantitative determination of Creatine Kinase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of creatine phosphokinase activity are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchennetype muscular dystrophy. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
V 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 Device Evaluation (ODE) | Division Sign-Off |
|---|---|
| Acting | |
| August 6, 2008 | Office of In Vitro Diagnostic DeviceEvaluation and SafetyCONFIDENTIAL |
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§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.