The Lipid Panel Test Strips are intended to measure cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism , or various endocrine disorders.

The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.

Device Description

The BioScanner Plus is a reflectance photometer for in vitro diagnostic use with Polymer Technology System's (PTS) test strips to measure color developed in a chemical reaction that occurs when whole blood is placed on a test strip. The color is measured and converted into concentration for each analyte.

The Lipid Panel Test Strips are dry phase test strips that are constructed from a plastic strip holder that holds chemically treated membranes. When whole blood is placed on the test strip, the membranes first separate and isolate the red blood cells, allowing the serum/plasma to flow to the reaction membranc and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus reflectance photometer.

The only modification that was made to the BioScanner to produce the BioScanner Plus was: A fourth optical read window was added to the three optical read windows in the BioScanner.

The only modification that was made to the Cholesterol, HDL Cholesterol and Triglycerides test strips to produce the Lipid Panel Test Strips is that the reaction membranes from the three individual test strips were assembled together on one test strip holder that holds all three at once.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BioScanner Plus Lipid Panel Test Strips, based on the provided 510(k) summary:

This document is a 510(k) summary for a medical device modification, not a standalone study report. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria or a comprehensive study analysis of a novel device. Therefore, some information requested, particularly regarding detailed acceptance criteria, specific performance metrics, sample sizes for test sets, expert-derived ground truth, and MRMC studies, is not explicitly present in this type of submission. The focus is on comparing the modified device's performance to the predicate device's established performance.

1. Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state numerical acceptance criteria (e.g., specific accuracy, precision, or correlation thresholds). Instead, the criterion for acceptance is "substantial equivalence" to the predicate device. This implies that the modified device (BioScanner Plus and Lipid Panel Test Strips) must perform comparably to the predicate device (BioScanner and its individual Cholesterol, HDL Cholesterol, and Triglycerides Test Strips).

The "performance" described is the functionality and analytical method, with the implicit understanding that the analytical performance (accuracy, precision) would be equivalent to the predicate. The changes made were structural (four optical windows instead of three) and organizational (combining three test strips into one Lipid Panel Test Strip), not fundamental changes to the chemical reaction or measurement principle.

Metric	Acceptance Criteria (Implicit, based on substantial equivalence)	Reported Device Performance
Determination of Total Cholesterol, HDL Cholesterol, and Triglycerides	Equivalent to predicate device	Determines Total Cholesterol, HDL Cholesterol, and Triglycerides concentrations in whole blood
Method of Red Blood Cell Separation	Equivalent to predicate device	Uses the same method of red blood cell separation
Reaction Membranes	Equivalent to predicate device	Uses the same reaction membranes for blood separation and color development
Measurement Principle	Equivalent to predicate device	Uses a reflectance photometer to convert the intensity of color produced in a colorimetric chemical reaction into results
EEPROM Chip Functionality	Equivalent to predicate device	Incorporates a lot-specific EEPROM chip for curve information and a failsafe feature

2. Sample Size for the Test Set and Data Provenance

This information is not provided in the 510(k) summary. 510(k) summaries for device modifications often do not include the detailed sample sizes of validation studies if the modifications are considered minor and don't significantly alter the fundamental performance. The focus is on demonstrating that the changes do not negatively impact performance compared to the predicate, often through bridging studies rather than full-scale clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the 510(k) summary. Given that this is an in vitro diagnostic device measuring standard analytes, ground truth would typically be established using validated laboratory reference methods, not necessarily by human expert consensus as might be the case for image-based diagnostic aids.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done. This type of study is typically performed for diagnostic aids where human interpretation is involved (e.g., radiology AI). The BioScanner Plus is an automated in vitro diagnostic device for quantitative measurements; direct human reader involvement in the measurement process for improvement with AI assistance is not applicable here.

6. Standalone Performance Study (Algorithm Only)

The 510(k) summary describes a standalone device (BioScanner Plus with Lipid Panel Test Strips). However, it does not detail a specific "algorithm only" study in the sense of comparing an AI algorithm's performance in isolation. The device itself is the "algorithm only" in the context of its chemical and optical measurement system. The performance is assessed by comparing its output (analyte concentrations) to accepted reference methods or the predicate device, not by comparing an AI algorithm's output to human expert readings.

7. Type of Ground Truth Used for the Test Set

The type of ground truth used would almost certainly be reference laboratory methods (e.g., enzymatic assays, gas chromatography-mass spectrometry, or other established analytical methods) for Cholesterol, HDL Cholesterol, and Triglycerides. This is standard practice for validating in vitro diagnostic devices. However, the specific methods are not detailed in this summary.

8. Sample Size for the Training Set

This information is not provided in the 510(k) summary. The BioScanner Plus is a reflectance photometer, which uses a chemical reaction and optical detection, not an AI or machine learning algorithm that typically requires a distinct "training set" in the common sense. The "training" in this context refers to the calibration curves established for each lot of test strips.

9. How the Ground Truth for the Training Set Was Established

The "ground truth" for the "training set" (calibration) in this device is established via a multipoint curve that is set for each lot of test strips. This involves measuring known concentrations of the analytes (standards) to generate a calibration curve. This curve information is then programmed into a lot-specific electronically erasable programmable read-only memory (EEPROM) chip. The exact methods for determining the "known concentrations" (standards) are not detailed in this summary but would involve highly accurate reference methods.

Summary

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K 013/73

510(k) SUMMARY

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

1. Application Date:
  September 11, 2001

2. Applicant Information:

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: mme@diabetes-testing.com

1. Trade Names:
  BioScanner Plus Lipid Panel Test Strips
1. Description:
  The BioScanner Plus is a reflectance photometer for in vitro diagnostic use with Polymer Technology System's (PTS) test strips to measure color developed in a chemical reaction that occurs when whole blood is placed on a test strip. The color is measured and converted into concentration for each analyte.

The only modification that was made to the BioScanner to produce the BioScanner Plus was: A fourth optical read window was added to the three optical read windows in the BioScanner.

રું. Classification Names:

Cholesterol test system Lipoprotein test system Panel: Clinical Chemistry 75

Panel: Clinical Chemistry 15

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

7. Device Classification:

Class I (Regulation: 21 CFR 862.1475. 862.1175. 862.1705)

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8. Intended Use:

The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus analyzer. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

9. Reason for 510(k):

Device Modification

Predicate Device Information 10.

The following are the predicate devices for determination of substantial equivalence:

Name: BioScanner, BioScanner Cholesterol, HDL Cholesterol and Triglycerides Test Strips from Polymer Technology Systems

Device Company: Polymer Technology Systems, Inc. 510(k) Numbers: K972669, K981493, K990247, and K991894

Similarities and Differences between BioScanner Plus and the Predicate Device

Similarities

Both systems determine Total Cholesterol, HDL Cholesterol, and ● Triglycerides concentrations in whole blood.
Both systems use the same method of red blood cell separation. .
Both systems use the same reaction membranes for blood separation and . color development.
Both systems use a reflectance photometer to convert the intensity of color ● produced in a colorimetric chemical reaction into total cholesterol, HDL cholesterol, and Triglycerides results.
. Both systems contain a lot specific electronically erasable programmable read-only memory (EEPROM) chip in the same package with the strips. The EEPROM chip has the curve information programmed into it based on a multipoint curve that is established for each lot. The user inserts this chip into the meter with each new lot of test strips.
t Both systems contain, on the EEPROM, the failsafe feature ensuring that the test strip lot and calculation EEPROM match. If the EEPROM and strip lot number do not match, an error message is displayed.

Differences

1. The BioScanner Test System (K972669) has three optical windows
  The BioScanner Plus has four optical windows.
1. The BioScanner Test System Cholesterol (K981493), HDL Cholesterol (K990247) and Triglycerides (K991894) Test Strips are constructed on three separate strips. The Lipid Panel Test Strips combine the cholesterol, HDL cholesterol and triglycerides into one test strip.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 22 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. James M. Connolly, CEO Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268

Re: K013173

Trade/Device Name: BioScanner Plus and Lipid Panel Test Strips Regulation Number: 21 CFR 862.1175, 21 CFR 862.1475, 21 CFR 862.1705 Regulation Name: Cholesterol (total) test system, Lipoprotein test system, Triglyceride test system Regulatory Class: Class I, reserved, Class I, reserved, Class I, reserved Product Code: CHH, LBR, JGY Dated: September 11, 2001 Received: September 24, 2001

Dear Mr. Connolly:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and w you diving of substantial equivalence of your device to a legally marketed noutication. The I Drivinant of Scation for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 If you desire specific datable for your ostic devices), please contact the Office of Compliance at additionally 607.10 for questions on the promotion and advertising of your device, (201) 594-1560. Tradition for at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilites under the Act may be obtained from the Division of Small mornation on your respondiationsumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Selecss "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510 (K) NUMBER (IF KNOWN) : _ KU13173

BioScanner Plus and Lipid Panel Test Strips DEVICE NAME:

INDICATIONS FOR USE:

The BioScanner Plus is intended to be used by healthcare professionals to measure blood analytes on a test strip.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Fer 21 CFR 801.109)

Over-The-Counter-Use er-The-Councer 33-96)

Kesia Alexander for Tim Cooper

(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K013173

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.