ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY

K071587 · Inverness Medical Innovations, Inc. · JJX · Jul 30, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071587
• Device Name: ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAY
• Applicant: Inverness Medical Innovations, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation. For In Vitro Diagnostic Use.

Device Story

The ACB Assay Verification Set (AVS) consists of frozen, serum-based samples with assigned Ischemia Modified Albumin (IMA) values. It serves as a quality control tool for clinical laboratory personnel to verify the accuracy of the ACB Test during the installation of the assay on Roche INTEGRA 700/800, Roche/Hitachi 917, and Roche MODULAR P analyzers. By processing these samples, the laboratory confirms that the analyzer correctly measures IMA levels within the physiological range, ensuring the system is calibrated and performing within established specifications before clinical use. This verification process supports the reliability of subsequent patient test results used in clinical decision-making.

Clinical Evidence

Bench testing only; design control activities and verification/validation performed to confirm that modifications meet predetermined acceptance criteria.

Technological Characteristics

In vitro diagnostic analytical platform accessory; modifications involve range value assignment criteria for Roche Diagnostics 917 and Modular P analyzers; design control procedures per 21 CFR 820.30.

Indications for Use

Indicated for use as a quality control material to verify the accuracy of the ACB Test on specific clinical chemistry analyzers during assay installation. No specific patient population is described as this is an in vitro diagnostic control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• k060133

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 k071587

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I device requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. k060133
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 MODIFICATIONS, including clearly labeled diagrams and user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

These changes are to expand applicability to include the Roche Diagnostics 917 and Modular P analytical platforms and to change the acceptance criteria for range value assignment to accommodate the additional analyzers.

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

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 and the Indications for Use Enclosure.

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 modifications 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.