VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

K060650 · Ortho-Clinical Diagnostics, Inc. · LCP · Apr 6, 2006 · Hematology

Device Facts

• Record ID: K060650
• Device Name: VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: LCP · Hematology
• Decision Date: Apr 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

VITROS Chemistry Products d%A1c Reagent Kit is used to determine the percent glycated hemoglobin (%A1c) in human whole blood by quantitative measurement of hemoglobin (Hb) and hemoglobin A1c (HbA1c). Measurements of percentage Alc are effective in monitoring long-term glycemic control in individuals with diabetes mellitus. VITROS Chemistry Products Calibrator Kit 18 is used in conjunction with VITROS Chemistry Products FS Calibrator 1 to calibrate VITROS 5,1 FS Chemistry Systems for the calculation of percent glycated hemoglobin (%A1c). VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits 16, 17, 18, 19 and 28 to calibrate VITROS 5,1 FS Chemistry Systems.

Device Story

The VITROS d%A1c assay is an in vitro diagnostic test for monitoring long-term glycemic control in diabetic patients. The system utilizes whole blood samples (EDTA) processed on the VITROS 5,1 FS Chemistry System. Unlike the predicate, which required manual sample pretreatment, this device automates hemolysis on-board using a hemolyzing reagent (containing TTAB) integrated into the reagent pack. The assay employs a turbidimetric inhibition immunoassay principle to measure HbA1c and total Hb. The system calculates %A1c based on these measurements. The device is intended for use in clinical laboratory settings by trained laboratory personnel. Results assist healthcare providers in assessing long-term glucose control, enabling adjustments to diabetes management plans. The system includes specific calibrator kits (Kit 18 and FS Calibrator 1) to ensure measurement accuracy.

Clinical Evidence

Bench testing only. Includes precision testing, accuracy testing, method comparison, and stability testing to verify performance following process modifications.

Technological Characteristics

Turbidimetric inhibition immunoassay. Reagents: dual-chambered packs containing ovine HbA1c antibody, polyhapten, buffers, stabilizers, preservatives, and TTAB-based hemolyzing reagent. Instrumentation: VITROS 5,1 FS Chemistry System. Sample type: EDTA whole blood. Calibration: lyophilized hemolysate calibrators. Connectivity: system-integrated.

Indications for Use

Indicated for the quantitative measurement of hemoglobin A1c (HbA1c) and total hemoglobin (Hb) in human whole blood to determine percent glycated hemoglobin (%A1c). Used for monitoring long-term glycemic control in individuals diagnosed with diabetes mellitus.

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

• k041764
• k052645

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 k060650

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.) k041764, k052645
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 combining two sequential steps in an automated assay and limiting the sample type to EDTA plasma.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and precision testing, accuracy testing method comparison, and stability 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.
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.

Revised: 8/1/03