PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS

K071507 · Polymer Technology Systems, Inc. · NBW · Sep 10, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071507
• Device Name: PTS PANELS CHOL+HDL+GLU PANEL TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

PTS PANELS CHOL+HDL+GLU Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol. high density lipoprotein cholesterol and glucose in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. Glucose measurements are used by individuals with diabetes to measure glucose in fingerstick whole blood at home for the management of carbohydrate metabolism disorders.

Device Story

PTS PANELS CHOL+HDL+GLU Panel Test Strips; multi-analyte test strip combining three tests (cholesterol, HDL-cholesterol, glucose) into single strip. Input: 35 uL whole blood sample. Operation: user applies sample to strip; device performs colorimetric/enzymatic analysis; results obtained in approximately two minutes. Used in point-of-care settings; operated by healthcare professionals. Output: quantitative concentration values for cholesterol, HDL, and glucose. Modification from previous single-test strips includes increased sample volume (15 uL to 35 uL) and consolidated test format.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing comparing the performance of the integrated single-strip format to the predicate multi-strip system.

Technological Characteristics

Multi-analyte test strip; enzymatic/colorimetric sensing principle; requires 35 uL whole blood sample; test time approximately 2 minutes.

Indications for Use

Indicated for the quantitative determination of cholesterol, HDL-cholesterol, and glucose in whole blood.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• PTS PANELS Cholesterol Test Strips (K981493)
• PTS PANELS Cholesterol Test Strips (K990688)
• PTS PANELS HDL Cholesterol Test Strips (K060617)
• PTS PANELS Glucose Test Strips (K013068)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k071507

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.) Cholesterol: k981493 and k990688 ; HDL: k060617; Glucose: k013068

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. Combining 3 single test strips into 1 strip with 3 tests for cholesterol, HDL-cholesterol and glucose.
B. Changing the name of device to PTS PANELS CHOL+HDL+GLU Panel Test Strips.
C. Increasing the sample volume from 15 uL to 35 uL.
D. Changing the time to obtain a test result from 1 minute for each test to approximately two minutes for all three tests.

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.