DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID

K080618 · Jas Diagnostics, Inc. · LCP · May 23, 2008 · Hematology

Device Facts

• Record ID: K080618
• Device Name: DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
• Applicant: Jas Diagnostics, Inc.
• Product Code: LCP · Hematology
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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 Story

JAS Diagnostics reagent sets for quantitative determination of glucose, hemoglobin A1c, and fructosamine in human serum/blood samples. Used in clinical laboratory settings by trained personnel. Reagents react with patient samples to produce measurable signals corresponding to analyte concentration; results used by clinicians to assess glycemic control and diagnose carbohydrate metabolism disorders. Provides longitudinal monitoring of glucose levels (fructosamine: 2-3 weeks; HbA1c: 4-8 weeks). Benefits include improved management of diabetes and related metabolic conditions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on reference to previously cleared devices.

Technological Characteristics

In vitro diagnostic reagent sets for clinical chemistry analysis. Utilizes standard biochemical assay principles for glucose oxidase, hemoglobin A1c, and fructosamine quantification. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for quantitative determination of glucose, hemoglobin A1c, and fructosamine in human serum or blood to evaluate glycemic control in patients with diabetes mellitus, carbohydrate metabolism disorders, neonatal/idiopathic hypoglycemia, or pancreatic islet cell carcinoma. For in vitro diagnostic use only.

Regulatory Classification

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.

Predicate Devices

• k080617
• k070614

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k080618

B. Purpose for Submission:
Notification of intent to manufacture and market a new device for the determination of Fructosamine, Glucose, and Hemoglobin A1c (HgbA1c).

C. Measurand:
Fructosamine, Glucose, HgbA1C

D. Type of Test:
Fructosamine, Glucose – Colorimetric
HgbA1c – latex turbidometric immunoassay

E. Applicant:
Current applicant JAS Diagnostics (Referenced Pointe Scientific k993590, k970781, and k031539).

F. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

G. Conclusion:
The submitted information in this premarket notification is entirely by reference to Pointe Scientific devices cleared under k993590, k970781, and k031539. A substantial equivalence decision is based on previous clearance of those files.