(90 days)
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No
The summary describes calibrators, controls, and reagents for a quantitative determination of Hemoglobin A1c. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device appears to be a standard in vitro diagnostic assay.
No.
The device is used for calibrating results and monitoring accuracy/precision in the determination of hemoglobin A1c levels, which is a diagnostic tool for evaluating glycemic control in diabetes mellitus, not a treatment device.
Yes
The device is described as being for "the quantitative determination of human hemoglobin A1c (HbA1c)... most commonly performed for the evaluation of glycemic control in diabetes mellitus." This indicates it provides information used to diagnose or monitor a medical condition.
No
The device description is not available, but the intended use clearly describes calibrators, controls, and a reagent set for determining Hemoglobin A1c in human blood. These are physical components used in a laboratory setting, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Teco Hemoglobin A1c Calibrators are for calibrating results in the quantitative determination of human hemoglobin A1c (HbArt)..."
- "Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemogiobin A1c (HbAn)."
- "Teco Hemogiobin A1c Reagent set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood."
- "For in vitro diagnostic use only."
These statements clearly indicate that the device is intended to be used outside of the body (in vitro) to diagnose or monitor a medical condition (diabetes mellitus) by analyzing a human sample (blood). The final statement "For in vitro diagnostic use only" confirms its classification as an IVD.
N/A
Intended Use / Indications for Use
Teco Hemoglobin A1c Calibrators are for calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) and Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemogiobin A1c (HbA1c). Teco Hemogiobin A1c Reagent set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.
Product codes
LCP, JIS, JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's focus on health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.
Public Health Service
AUG 8 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jian Vaeches Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807
Re: K051200
Trade/Device Name: Hemoglobin A1c Reagent Set, Calibrators, and Controls Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, JIS, JJX Dated: July 15, 2005 Received: July 15, 2005
Dear Mr. Vaeches:
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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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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. 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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TECO DIAGNOSTICS
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1268 N. Lakeview Ave., Anaheim, CA 92807, U.S.A. Phone: (714) 693-7788 Toll Free: 1-800-222-9880 Fax: (714) 693-3838 www.tecodiag.com Email:tecodiag@tecodiag.com
Indications for Use
05/200 510(k) Number (if known): Unknown at this time
Device Name: Hemoglobin A1c Reagent Set ; Calibrators and Controls
Indications For Use: Teco Hemoglobin A1c Calibrators are for calibrating results in the quantitative determination of human hemoglobin A1c (HbArt) and Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemogiobin A1c (HbAn). Teco Hemogiobin A1c Reagent set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.
Prescription Use_ ____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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