(184 days)
Not Found
No
The summary describes a standard in vitro diagnostic reagent and analyzer based on colorimetric and enzymatic assays, with no mention of AI or ML.
No
The device is an in vitro diagnostic reagent used to measure Hemoglobin A1c levels for monitoring diabetes, not for treating or preventing disease directly.
Yes
The S-Test Hemoglobin A1c Reagent is intended for the quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood, which is used for monitoring long-term glycemic control in individuals with diabetes. This directly supports diagnosis and monitoring of a medical condition.
No
The device is described as a reagent cartridge used with a clinical analyzer, indicating it is a physical component and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The statement explicitly says "For in vitro diagnostic use only." It also describes the device's purpose as the "quantitative determination of percent Hemoglobin A1c concentration in EDTA whole blood," which is a test performed on a biological sample outside of the body to provide information for diagnosis or monitoring.
- Device Description: The description reiterates that the reagent cartridges are intended for "quantitative in vitro diagnostic determination of %HbA1c concentration in EDTA whole blood."
These statements clearly indicate that the device is designed and intended for use in diagnostic procedures performed on samples taken from the human body.
N/A
Intended Use / Indications for Use
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.
Product codes
LCP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories or physician office laboratories.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Performance data on S-Test HbA1c reagent included precision and accuracy data.
Precision: In testing at three HbA1c levels for 20 days, the within-run CV ranged from 0.9 to 1.1% and total CV ranged from 1.2 to 1.5%. In precision studies at three separate Physician Office Laboratory (POL) sites over five days, the within-run CV ranged from 0.5 to 1.8% and total CV ranged from 0.7 to 3.2%.
Accuracy: In a correlation study, 110 EDTA whole blood samples with HbA1c values ranging from 4.0 to 13.4% were assayed on the S40 Clinical Analyzer using S-Test HbA1c (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.982, a standard error estimate of 0.39, a confidence interval slope of 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 S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 0.988 to 0.996, standard error estimates of 0.18 to 0.31, confidence interval slopes of 0.957 to 1.065, and confidence interval intercepts of -0.64 to 0.16.
Key Metrics
Precision: within-run CV ranged from 0.5% to 1.8%, total CV ranged from 0.7% to 3.2%.
Accuracy/Correlation: correlation coefficient of 0.982 (single study), 0.988 to 0.996 (multiple studies).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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510(k) SUMMARY
DEC 1 1 2009
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Hyman Katz, Ph.D.
Phone: 973-852-0158
Fax: 973-852-0237 |
| Date Summary
Prepared: | June 8, 2009
(updated November 6, 2009) |
| Device: | Trade Name:
S-Test HbA1c Reagent cartridge
Classification:
Class II |
| | Assay, Glycosylated Hemoglobin
Common/Classification Name:
(21 C.F.R. § 864.7470), Product
code LCP |
| Predicate
Devices: | Manufacturer for analyzer/reagent system predicate:
Siemens Medical Solutions Diagnostics, DCA Vantage (K071466) and
DCA 2000+ Analyzer (K951361), Test system for Hemoglobin A1c |
| Device
Description: | 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. |
| Intended Use: | 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. |
| Technological
Characteristics: | The S-Test HbA1c Reagent is contained in two bi-reagent cartridges.
Cartridge 1, Reagent 1 contains Protease and ProClin 300; Reagent 2
contains N-ethylmaleimide and ProClin 300. Cartridge 2, Reagent 1
contains N-(carboxymethyl aminocarbonyl)-4,4-bis(dimethylamino)
diphenylamine sodium salt (20 µmol/L), surfactant, ProClin 300, and
sodium azide (0.001%); Reagent 2 contains surfactant, fructosyl
peptide oxidase, and peroxidase. |
| Performance
Data: | Performance data on S-Test HbA1c reagent included precision and
accuracy data. |
| | Precision: In testing at three HbA1c levels for 20 days, the within-run
CV ranged from 0.9 to 1.1% and total CV ranged from 1.2 to 1.5%. In
precision studies at three separate Physician Office Laboratory (POL)
sites over five days, the within-run CV ranged from 0.5 to 1.8% and
total CV ranged from 0.7 to 3.2%. |
| | Accuracy: In a correlation study, 110 EDTA whole blood samples with
HbA1c values ranging from 4.0 to 13.4% were assayed on the S40
Clinical Analyzer using S-Test HbA1c (y) and a comparative method
(x). Least-squares regression analysis yielded a correlation coefficient
of 0.982, a standard error estimate of 0.39, a confidence interval slope
of 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 S40
Clinical Analyzer and a comparative method, least-squares regression
analysis yielded correlation coefficients of 0.988 to 0.996, standard
error estimates of 0.18 to 0.31, confidence interval slopes of 0.957 to
1.065, and confidence interval intercepts of -0.64 to 0.16. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These
data also indicate substantial equivalence to the predicate devices. |
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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).
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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,
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
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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