DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT

K110188 · Diazyme Laboratories · LCP · May 17, 2011 · Hematology

Device Facts

• Record ID: K110188
• Device Name: DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT
• Applicant: Diazyme Laboratories
• Product Code: LCP · Hematology
• Decision Date: May 17, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Diazyme Glycated Serum Protein (GSP) Assay is an in vitro diagnostic test for the quantitative determination of glycated serum protein (fructosamine) in human serum. The measurement of glycated serum protein is intended for use as an aid in the management of patients with diabetes.

Device Story

Enzymatic assay for quantitative measurement of glycated serum protein (fructosamine) in human serum; used as aid in diabetes management. Modification: transition from lyophilized reagents to ready-to-use liquid two-reagent format. Assay performance improved: within-run and total precision improved from <3.0% CV to <2.0% CV. Device used in clinical laboratory settings by trained personnel. Output provides quantitative fructosamine levels to assist clinicians in monitoring glycemic control.

Clinical Evidence

Bench testing only. Studies included method comparison, linearity, precision, limits of detection, and interference studies. Precision improved to <2.0% CV (within-run and total).

Technological Characteristics

Enzymatic assay; liquid two-reagent format. Quantitative measurement of glycated serum protein. Performance specifications: within-run precision <2.0% CV, total precision <2.0% CV.

Indications for Use

Indicated for the quantitative determination of glycated serum proteins (GSP, glycated albumins, fructosamine) in serum to monitor diabetic patients.

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

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k110188

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.) Diazyme Glycated Serum Protein Enzymatic Assay k042193

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: Modification to the reagents from lyophilized to a ready to use liquid two-reagent form. The precision of the assay has changed from a within-run precision of &lt; 3.0 % CV and a total precision of &lt; 3.0 % to a within-run precision of &lt; 2.0 % CV and a total precision of &lt; 2.0 % CV.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison analysis. Studies performed include method comparison, linearity, precision, limits of detection, and interference studies.

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

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.