LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT

K062808 · Catch Incorporated · LPS · Oct 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062808
• Device Name: LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT
• Applicant: Catch Incorporated
• Product Code: LPS · Clinical Chemistry
• Decision Date: Oct 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Indications for Use

Intended for the in vitro quantitative determination of total homocysteine in serum and plasma.

Device Story

Modification to previously cleared Class II/III device; involves combining two component reagents into single reagent; modification improves reagent stability; fundamental scientific technology remains unchanged; design control activities performed to verify and validate modification impact.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm stability improvements.

Technological Characteristics

Reagent-based diagnostic device; modification involves combining two component reagents into a single reagent to improve stability.

Indications for Use

Indicated for in vitro quantitative determination of total homocysteine in serum and plasma to assist in diagnosis and treatment of patients suspected of having homocystinuria and hyperhomocysteinemia.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

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 K062808

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.)
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.

The change was for combining two component reagents into a single reagent with improved stability.

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 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.