MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON

K070734 · Diazyme Laboratories · LCP · Apr 9, 2007 · Hematology

Device Facts

• Record ID: K070734
• Device Name: MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON
• Applicant: Diazyme Laboratories
• Product Code: LCP · Hematology
• Decision Date: Apr 9, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.

Device Story

The Diazyme Direct Enzymatic HbA1c Assay is an in-vitro diagnostic reagent kit used for the quantitative measurement of stable HbA1c in human whole blood. The assay utilizes an enzymatic method to determine HbA1c levels, which serves as a clinical indicator for long-term glycemic control in diabetic patients. The device is intended for professional use in clinical laboratory settings. By providing accurate HbA1c measurements, the assay assists healthcare providers in assessing a patient's average blood glucose levels over the preceding weeks to months, thereby informing clinical decisions regarding diabetes management and treatment adjustments.

Clinical Evidence

No clinical data provided in the document; the submission relies on the demonstration of substantial equivalence to legally marketed predicate devices for in-vitro diagnostic use.

Technological Characteristics

In vitro diagnostic reagent system. Modifications: reagent count reduced from 4 to 3; component concentration adjusted; calculation algorithm updated to NGSP format. Design controls per 21 CFR 820.30 applied.

Indications for Use

Indicated for quantitative determination of stable HbA1c in human whole blood samples to monitor long-term diabetic control. For in-vitro diagnostic use.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k070734

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k050178
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for change in the number of reagents supplied (from 4 to 3), change in concentration of component in reagent, change in calculation equation to direct reporting in %HbA1c values in the NGSP format, and labeling changes to reflect the modifications.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and precision testing, accuracy testing, linearity testing.
5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis - FMECA
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.