PTS PANELS CHOL+HDL PANEL TEST STRIPS

K071593 · Polymer Technology Systems, Inc. · CHH · Oct 15, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071593
• Device Name: PTS PANELS CHOL+HDL PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Oct 15, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The PTS PANELS CHOL+HDL Panel Test Strips are intended for the quantitative determination of total cholesterol and HDL cholesterol in whole blood. The PTS PANELS CHOL+HDL Panel Test Strips are intended for use with the CardioChek PA and CardioChek Plus professional analyzers. The system is intended for use by healthcare professionals in a clinical setting.

Device Story

PTS PANELS CHOL+HDL Panel Test Strips combine total cholesterol and HDL cholesterol testing onto single strip; used with CardioChek PA/Plus professional analyzers. Input: 30 uL whole blood sample. Operation: enzymatic reaction on test strip; analyzer measures reflectance/colorimetric change. Output: quantitative cholesterol levels displayed on analyzer screen. Used in clinical settings by healthcare professionals. Modification from predicate: combined two tests into one strip; increased sample volume from 15 uL to 30 uL; increased test time from one to two minutes. Clinical decision-making: results used for lipid profile assessment and cardiovascular risk management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing comparing the modified single-strip format to the predicate two-strip format.

Technological Characteristics

Enzymatic reflectance-based test strips. Analyte: total cholesterol and HDL cholesterol. Sample: 30 uL whole blood. Test time: 2 minutes. Compatible with CardioChek PA and CardioChek Plus professional analyzers. Design controls per 21 CFR 820.30.

Indications for Use

Indicated for quantitative determination of total cholesterol and HDL cholesterol in whole blood. Intended for use by healthcare professionals in clinical settings using CardioChek PA and CardioChek Plus 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

• PTS PANELS Cholesterol test strips (k981493, k990688)
• PTS PANELS HDL Cholesterol test strips (k060617)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k071593

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.) PTS PANELS Cholesterol test strips: k981493,k990688 and PTS PANELS HDL Cholesterol test strips: k060617

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:

A. Name change to PTS PANELS CHOL+HDL Panel Test Strips.
B. Combine two separate tests into one test strip.
C. Increase sample volume from 15 uL to 30 uL.
D. Time to obtain test results from one minute to two minutes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, analytes and performance characteristics. Studies include precision and method comparison with an automated laboratory analyzer.

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. FMEA
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.