(541 days)
The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The concentration of the HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application is intended for the Hitachi instrument and is to be used by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.
The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The method claimed is an immunological assay. Both the concentration of the HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. This test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.
The provided document is a 510(k) summary for a medical device (LIQUI-HEME Glycohemoglobin A1c Assay) and does not contain detailed study information, acceptance criteria, or performance data in the format requested.
Specifically, this document is a regulatory approval letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device. It states the device name, regulation number, regulatory class, and product codes, along with its indications for use.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory approval, not detailed performance metrics.
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 available. This device is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of device.
- The type of ground truth used: Not available. The device measures HbA1c, and ground truth would typically be established by a reference method, but details are not provided.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
The document primarily states that the device is an "In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood" and that "Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus." It also mentions that "This application report has been validated for the Hitachi instrument of clinical chemistry analyzers by suitably qualified personnel under appropriate clinical laboratory conditions." However, the specific data, acceptance criteria, and study details that would back up these statements are not included in this regulatory letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a common symbol associated with healthcare and medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 5 2004
Paul Anand, Ph.D. Director BioDiagnostic International 615 North Berry St. # E Brea, CA 92821
K031296 Re: Trade/Device Name: LIQUI-HEME Glycohemoglobin A1c Assay LIQUI-HEME Hemoglobin Alc Control Set LIQUI-HEME Hemoglobin Alc Calibrators Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ, JJX Dated: October 1, 2004 Received: October 4, 2004
Dear Dr. Anand:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, U.S. DVM.
Jean M. Cooper, MS, 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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Indications for Use
510(k) Number (if known): K031296
Device Name: LIQUI-HEME Glycohemoglobin A1c Assay
Indications For Use:
The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro The DioDiagnostic reagent for the Styconomission of Glycohemoglobin A1c (HbA1c)
Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) Diagnostic reagent for the quarklained is an immunological assay. Both the in the numan whole blood. The momentration of the total hemoglobin are measured. Concentration of The and the culated as a percentage of the total hemoglobin concentration.
concentration.
Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
Control in Individuals with diaboted for the Hitachi instrument of clinical This application onoot has been by suitably qualified personnel under appropriate clinical laboratory conditions.
Cillifical laboratory conditions:
Further ,this test kit also includes a set of six calibrators and bilevel(Human) Low and High controls, which are optional.
Prescription Use __ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert S
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) _k031296
§ 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).