DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID by JAS Diagnostics, Inc.

This product is to be used for the quantitative determination of glucose oxidase in human serum. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia and of pancreatic islet cell carcinoma. This reagent set is intended for in vitro diagnostic use only.

This product is to be used for the quantitative determination of hemoglobin A 1 c in human blood. The determination of hemoglobin A 1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A 1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A 1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

This product is to be used for the quantitative determination of fructosamine in human serum. The determination of fructosamine is most commonly performed for the evaluation of glycemic control in diabetes. Fructosamine values provide an indication of glucose levels over the preceding 2-3 weeks. A higher fructosamine value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) summary from the FDA, which is a regulatory document and does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment. This document primarily outlines the substantial equivalence determination for the JAS Diagnostics Fructosamine, Glucose Oxidase, and Hemoglobin A1c test kits to legally marketed predicate devices.

Therefore, I cannot extract the information required to fill out the table and answer the questions.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAS Diagnostics c/o Sam Burgos 7220 N.W. 58th Street Miami FL 33166

MAY 2 3 2008

Re: K080618

Trade/Device Name: JAS Diagnostics Fructosamine, Glucose Oxidase and Hemoglobin Alc

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LCP, CGA Dated: February 25, 2008 Received: March 10, 2008

Dear Mr. Burgos:

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) 276-0490. 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 vours.

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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Indication for Use

510(k) Number (if known): K080618

Device Name: Glucose Oxidase

Indication For Use:

Prescription Use _ √ _ (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 (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080617

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Indication for Use

510(k) Number (if known): K080618

Device Name: Hemoglobin Alc

Indication For Use:

Prescription Use _ √ (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)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070614

Page 2 of 3

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Indication for Use

510(k) Number (if known): K080618

Device Name: Fructosamine

Indication For Use:

Prescription Use (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)

Signature

Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K080617

Regulation Number and Section

§ 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).