PTS PANELS CHOL+GLU TEST PANEL

K041750 · Polymer Technology Systems, Inc. · NBW · Jul 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041750
• Device Name: PTS PANELS CHOL+GLU TEST PANEL
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED.

Device Story

Modified test strip for simultaneous measurement of total cholesterol and glucose; combines functionality of previously cleared single-test strips (K972669, K981493, K013068). Used with Polymer Technologies Systems BioScanner devices. Operates via established biochemical sensing technology; no change to fundamental scientific technology. Intended for clinical or professional use to provide diagnostic data for patient management. Modification verified through FMEA risk analysis and design control activities per 21 CFR 820.30.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

Dry-phase test strip; plastic holder with chemically treated membranes. Enzymatic chemistry: glucose oxidase (glucose) and cholesterol esterase/oxidase (cholesterol). Reflectance photometry sensing. Calibration via EEPROM chip. Compatible with BioScanner Plus (CardioChek) analyzer. Specimen: whole blood (fingerstick or venous).

Indications for Use

Indicated for the measurement of total cholesterol and glucose levels in blood samples, consistent with previously cleared single-test strip indications.

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

• Polymer Technologies Systems BioScanner 1000/BioScanner G Test Strips (K972669)
• Polymer Technologies Systems BioScanner C Test Strip (K981493)
• Polymer Technologies Systems BioScanner Glucose Test Strips (K013068)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
OIVD Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K 041750

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. Polymer Technologies Systems BioScanner 1000/BioScanner G Test Strips (K972669), Polymer Technologies Systems BioScanner C Test Strip (K981493), and Polymer Technologies Systems BioScanner Glucose Test Strips (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. See page 6.
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 the combination of total cholesterol and glucose on one strip. Cholesterol and glucose were previously cleared as single-test strips.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance 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 (FMEA page 21).
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. See pages 34 and 35.

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.