(184 days)
The S-Test Hemoglobin A1c Reagent is intended for the quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Hemoglobin A1c (HbA1c) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of %HbA1c concentration in EDTA whole blood. This method is based on a colorimetric assay for total hemoglobin and an enzymatic assay for HbA1c.
Acceptance Criteria and Study Details for S-Test HbA1c Reagent Cartridge (K091711)
This document describes the acceptance criteria and supporting study details for the S-Test HbA1c Reagent cartridge, as presented in the 510(k) summary K091711.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the precision and accuracy data presented in the 510(k) summary. Given this is a diagnostic assay for a quantitative measure, the acceptance criteria are generally focused on demonstrating acceptable levels of precision and linearity/correlation with a comparative method.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision | ||
| Within-run CV | ≤ X% (typical clinical range) | 0.9 to 1.1% (3 HbA1c levels, 20 days, lab) 0.5 to 1.8% (3 POL sites, 5 days) |
| Total CV | ≤ Y% (typical clinical range) | 1.2 to 1.5% (3 HbA1c levels, 20 days, lab) 0.7 to 3.2% (3 POL sites, 5 days) |
| Accuracy | ||
| Correlation | Correlation coefficient $\ge$ 0.95 | 0.982 (110 samples, lab) 0.988 to 0.996 (3 POL sites) |
| Slope | 0.95 to 1.05 | Confidence Interval: 0.988 to 1.062 (lab) Confidence Interval: 0.957 to 1.065 (3 POL sites) |
| Intercept | Close to 0 (e.g., -0.5 to 0.5) | Confidence Interval: -0.48 to 0.02 (lab) Confidence Interval: -0.64 to 0.16 (3 POL sites) |
| Standard Error of Estimate | Clinically acceptable (e.g., < 0.5%) | 0.39 (110 samples, lab) 0.18 to 0.31 (3 POL sites) |
Note: The specific numerical acceptance criteria (e.g., maximum CV values, exact correlation coefficients) are not explicitly stated as "acceptance criteria" in the summary. However, the reported device performance is presented as evidence of meeting acceptable standards for a diagnostic device of this type, benchmarked against predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size (Accuracy Study): 110 EDTA whole blood samples.
- Data Provenance: The summary does not explicitly state the country of origin. It indicates studies conducted "in a correlation study" (presumably at the manufacturer's site or a central lab) and also "at three separate Physician Office Laboratory (POL) sites." The nature of the studies (correlation, precision over time) suggests retrospective and prospective components (e.g., samples collected and then tested, or runs performed over several days).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for this device (S-Test HbA1c) is established by a "comparative method" or "predicate device" which is itself a legally marketed and validated assay for HbA1c. Therefore, there are no human experts establishing a subjective "ground truth" (e.g., like a radiologist reading an image). The ground truth is the numerical result provided by the established comparative method.
4. Adjudication method for the test set
Not applicable. Since the ground truth is established by a quantitative comparative method, there is no need for expert 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
Not applicable. This is a standalone in vitro diagnostic assay, not an AI-assisted interpretation device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done for the S-Test HbA1c Reagent cartridge used with the S40 Clinical Analyzer. The reported precision and accuracy data reflect the performance of the device itself (reagent + analyzer) in measuring HbA1c concentrations without human interpretive input. The "comparative method" used for accuracy also represents a standalone, established laboratory technique.
7. The type of ground truth used
The ground truth used for the accuracy studies was the quantitative result obtained from a comparative method (likely a legally marketed and established HbA1c assay, potentially the predicate device mentioned earlier or another accepted reference method) run on the same patient samples.
8. The sample size for the training set
Not applicable. This is a chemical/enzymatic assay system, not a machine learning or AI-based device that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. (See #8).
{0}------------------------------------------------
510(k) SUMMARY
DEC 1 1 2009
| 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: | June 8, 2009(updated November 6, 2009) |
| Device: | Trade Name:S-Test HbA1c Reagent cartridgeClassification:Class II |
| Assay, Glycosylated HemoglobinCommon/Classification Name:(21 C.F.R. § 864.7470), Productcode LCP | |
| PredicateDevices: | Manufacturer for analyzer/reagent system predicate:Siemens Medical Solutions Diagnostics, DCA Vantage (K071466) andDCA 2000+ Analyzer (K951361), Test system for Hemoglobin A1c |
| DeviceDescription: | The S-Test Hemoglobin A1c (HbA1c) reagent cartridges, used with theS40 Clinical Analyzer, are intended for quantitative in vitro diagnosticdetermination of %HbA1c concentration in EDTA whole blood. Thismethod is based on a colorimetric assay for total hemoglobin and anenzymatic assay for HbA1c. |
| Intended Use: | The S-Test Hemoglobin A1c Reagent is intended for the quantitativedetermination of percent Hemoglobin A1c concentration in EDTAwhole blood using the S40 Clinical Analyzer. Measurement ofglycosylated hemoglobin is used for monitoring the long-term glycemiccontrol of individuals with diabetes. This test is intended for use inclinical laboratories or physician office laboratories. For in vitrodiagnostic use only. |
| TechnologicalCharacteristics: | The S-Test HbA1c Reagent is contained in two bi-reagent cartridges.Cartridge 1, Reagent 1 contains Protease and ProClin 300; Reagent 2contains N-ethylmaleimide and ProClin 300. Cartridge 2, Reagent 1contains N-(carboxymethyl aminocarbonyl)-4,4-bis(dimethylamino)diphenylamine sodium salt (20 µmol/L), surfactant, ProClin 300, andsodium azide (0.001%); Reagent 2 contains surfactant, fructosylpeptide oxidase, and peroxidase. |
| PerformanceData: | Performance data on S-Test HbA1c reagent included precision andaccuracy data. |
| Precision: In testing at three HbA1c levels for 20 days, the within-runCV ranged from 0.9 to 1.1% and total CV ranged from 1.2 to 1.5%. Inprecision studies at three separate Physician Office Laboratory (POL)sites over five days, the within-run CV ranged from 0.5 to 1.8% andtotal CV ranged from 0.7 to 3.2%. | |
| Accuracy: In a correlation study, 110 EDTA whole blood samples withHbA1c values ranging from 4.0 to 13.4% were assayed on the S40Clinical Analyzer using S-Test HbA1c (y) and a comparative method(x). Least-squares regression analysis yielded a correlation coefficientof 0.982, a standard error estimate of 0.39, a confidence interval slopeof 0.988 to 1.062, and a confidence interval intercept of -0.48 to 0.02.In patient correlation studies at three separate POL sites using the S40Clinical Analyzer and a comparative method, least-squares regressionanalysis yielded correlation coefficients of 0.988 to 0.996, standarderror estimates of 0.18 to 0.31, confidence interval slopes of 0.957 to1.065, and confidence interval intercepts of -0.64 to 0.16. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. Thesedata also indicate substantial equivalence to the predicate devices. |
{1}------------------------------------------------
and the comments of the comments of the country
:
:
. .
.
:
" " ...
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of a human figure, with three wavy lines emanating from the figure's head.
Alfa Wassermann Diag. Technologies, LLC c/o Dr. Hyman Katz Vice President, Ouality Assurance & Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
K091711 Re:
Trade Name: S-Test % Hemoglobin A1c (HbA1c) Regulation Number: 21 CFR §864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Codes: LCP Dated: November 24, 2009 Received: November 25, 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
DEC 11 2009
Dear Dr. 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 (QS) regulation (21 CFR Part 820).
{3}------------------------------------------------
Page 2 -
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,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indication for Use
510(k) Number (if known):
Device Name:
S-Test % Hemoglobin Alc (HbA)c)
Indication For Use:
The S-Test Hemoglobin Alc Reagent is intended for the quantitative determination of percent Hemoglobin Alc concentration in EDTA whole blood using the S40 Clinical Analyzer. Measurement of glycosylated hemoglobin is used for monitoring the long-term glycemic control of individuals with diabetes. 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)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K0917
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).