PTS PANELS HDL CHOLESTEROL TEST STRIPS

K060617 · Polymer Technology Systems, Inc. · NAQ · Apr 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060617
• Device Name: PTS PANELS HDL CHOLESTEROL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NAQ · Clinical Chemistry
• Decision Date: Apr 5, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The test strips are used with analyzers marketed as CardioChek and CardioChek PA analyzers.

Device Story

Test strips for lipid quantification; used with CardioChek and CardioChek PA analyzers. Modification involves change in lipid chemistry fractionation from phosphotungstic precipitation to dextran sulfate inhibition; blood separation membrane changed from glass fiber to non-glass fiber. Principle of operation remains cholesterol esterase/oxidase enzymatic reaction. Used in clinical settings by healthcare professionals to measure lipid levels; output provides quantitative lipid concentration data for clinical decision-making regarding patient cardiovascular health.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to assess impact of chemistry and membrane modifications. Results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

Lipid test strips; cholesterol esterase/oxidase enzymatic chemistry; dextran sulfate inhibition fractionation; non-glass fiber blood separation membrane. Designed for use with CardioChek and CardioChek PA analyzers.

Indications for Use

Indicated for the quantitative determination of lipids in blood samples using CardioChek and CardioChek PA analyzers.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Predicate Devices

• k990247
• k993377

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k060617

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.) k990247, k993377
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.
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 a change in the chemistry fractionation of the lipids from phosphotungstic precipitation to dextran sulfate inhibition and a change in the blood separation membrane from glass fiber to no glass fibers. Also, the test strips are used with analyzers marketed as CardioChek and CardioChek PA analyzers.

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

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.