The Chol+Glu Test Panel is intended to measure cholesterol and glucose in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The test strips are intended to be used by healthcare professionals and individuals at home to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Glucose measurements are used in the management of carbohydrate metabolism disorders.

Device Description

The Chol+Glu Test Panel is a dry phase test strip that is constructed from a plastic ship holder that holds chemically heated membranes. When whole blood is placed on the test ship, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membrane and react to produce a color change. The Chol+Glu Test Panel is for in vitro diagnostic use with a CardioChek brand (BioScanner Plus) reflectance photometer.

AI/ML Overview

The provided document describes the Chol+Glu Test Panel, a device intended to measure cholesterol and glucose in whole blood. However, the document does not contain explicit acceptance criteria or a dedicated study section detailing how the device meets such criteria in the format requested. Instead, it details the 510(k) submission process, a comparison with predicate devices, and general information about the device's intended use and technology.

Therefore, many of the requested fields cannot be directly extracted from the provided text. The information below is based on what can be inferred or directly stated in the document, acknowledging the limitations.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics like accuracy, precision, sensitivity, or specificity. However, it does provide the measuring ranges for the analytes, which serve as a de facto performance specification that the device must operate within.

Acceptance Criteria (Inferred from Measuring Ranges)	Reported Device Performance
Cholesterol:	Cholesterol:
Operates within 100-400 mg/dL	Not explicitly stated as "performance results" in this document, but implied to meet these ranges based on 510(k) clearance.
Glucose:	Glucose:
Operates within 20-600 mg/dL	Not explicitly stated as "performance results" in this document, but implied to meet these ranges based on 510(k) clearance.

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "The Chol+Glu Test Panel is for in vitro diagnostic use," but does not provide details about clinical study sample sizes, data provenance, or study design (retrospective/prospective). This information would typically be found in a more detailed clinical study report, not a 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. The document does not describe the establishment of ground truth by experts for a test set. For these types of devices, ground truth is typically established using a reference laboratory method rather than expert consensus on readings.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation). For a quantitative diagnostic device like this, ground truth is usually established by objective laboratory methods, not by expert adjudication of interpretations.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a dry-phase test strip for measuring cholesterol and glucose, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. Therefore, an MRMC study or AI assistance parameters are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical assay test strip that produces a quantitative result read by a photometer. There isn't an "algorithm only" performance concept in the way it applies to software-based diagnostic aids. The device itself generates the result.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred to be laboratory reference methods. For in vitro diagnostic devices measuring analytes like glucose and cholesterol, "ground truth" or reference values are typically established using highly accurate and precise laboratory-based analyzer methods (e.g., enzymatic reference methods in a clinical chemistry laboratory). The document does not explicitly state this, but it is standard practice for such devices.
The sample size for the training set:
- Not specified. The document does not distinguish between training and test sets or provide sample sizes for either. For a dry-phase chemical assay, the "training" aspect is more related to assay development and calibration rather than machine learning training.
How the ground truth for the training set was established:
- Not specified. Similar to point 7, the document does not detail how ground truth (or reference values for calibration/development) was established. It is presumed to be through highly accurate laboratory reference methods.

Summary

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APR 4 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

K041750 Re: Trade/Device Name: Cho+Glu Test Panel Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, CHH Dated: March 23,2005 Received: March 28,2005

Dear Ms. Enright:

This letter corrects our substantially equivalent letter of June 25, 2004 regarding the indications for is for your device. These types of devices are cleared for management of carbohydrate metabolism disorder and not for diagnosis of such disorders.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Jean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041750

Device Name: Chol+Glu Test Panel

Indications For Use:

Prescription Use_ × (Part 21 CFR 801 Subpart D) ANDVOR

Over-The-Counter Use × (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of _ 1

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K041750

JUL 2 3 2004

SECTION F: 510(k) Summary

510(k) SUMMARY

This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.

1. Application Date:

June 25.2004

Applicant Information: 2.

Polymer Technology Systems, Inc 7736 Zionsville Road Indianapolis, IN 46268 Contact Person: Margo Enright Phone Number: 317-870-5610 FAX Number: 317-870-5608 e-mail: menright@PTSpanels.com

3. Trade Names:

PTS PANELS Chol+Glu Test Panel

4. Description:

5. Classification Names:

Cholesterol test system Glucose test system Panel: Clinical Chemistry 75 Product Codes: CHH, CGA

1. Facility Address:
  7736 Zionsville Road Indianapolis, IN 46268

7. Device Classification:

Class I (Regulations: 21 CFR 862.1345 and 862.1175)

Intended Use: 8.

The Chol+Glu Test Panel is intended to measure cholesterol and glucose in whole blood on a CardioChek brand analyzer. The test strips are intended to he used by healthcare professionals to measure blood cholesterol and glucose. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. 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.

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1. Reason for 510(k): Device Modification
Predicate Device Information 10.

The predicate devices for determination of substantial equivalence are: Name: BioScanner (PTS PANELS) Cholesterol and Glucose Test Strips Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K013068

Similarities and Differences between Chol+Glu Test Panel and the Predicate Devices:

Item	Predicates	Modified Device
Intended Use	Intended to measure glucoseand cholesterol in wholeblood.	Same
Technology	Dry chemistry test strip foruse with PTS reflectancephotometer.	Same
MeasuringRanges	Cholesterol: 100-400 mg/dLGlucose: 20-600 mg/dL
ProductStorage	Store in cool dry place atroom temperature of 68-86°F.	Same
Specimen	Whole blood from fingerstickor venous blood collected inEDTA or heparin tube.	Same
ChemistryMethods	Glucose oxidase method forglucose and enzymatic(cholesterol esterase /oxidase) trinder method forcholesterol.	Same
CalibrationCurve	Resides on a read-onlymemory (EEPROM) chippackaged with the test strips.	Same

Similarities Between Predicate and Modified Device

Differences Between Predicate and Modified Pevice

Item	Predicates	Modified Device
Number ofanalytes pertest strip.	One test per strip. Separatecholesterol single test stripand separate glucose teststrip.	Modified devicecombinescholesterol andglucose into singletest strip.

Regulation Number and Section

§ 862.1345 Glucose test system.

(a)
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.(b)
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.