(21 days)
Not Found
No
The description focuses on the chemical reaction and photometric analysis of the test strips, with no mention of AI or ML. The performance improvement is attributed to manufacturing scale-up and experience, not algorithmic changes.
No
This device is an in vitro diagnostic (IVD) test strip used to measure cholesterol, HDL cholesterol, and triglycerides in whole blood. It is used for diagnosis and treatment planning, not for therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders." and similarly for lipoprotein and triglyceride measurements. This indicates the device is used for diagnostic purposes.
No
The device description clearly states that the device is a "dry phase test strip" constructed from a "plastic strip holder" and "chemically treated membranes," which are physical components, not software. It also mentions being used with a "reflectance photometer," which is a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test strips are "intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood" and that these measurements are "used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders," "lipid disorders," "atherosclerosis," "various liver and renal diseases," "diabetes mellitus," "nephrosis," "liver obstruction," "other diseases involving lipid metabolism," or "various endocrine disorders." This clearly indicates the device is used to analyze samples in vitro (outside the body) for diagnostic purposes.
- Device Description: The "Device Description" section states that the test strips are "for in vitro diagnostic use with the BioScanner Plus (CardioChek brand) reflectance photometer." This directly confirms its intended use as an IVD.
- Sample Type: The device analyzes "whole blood," which is a biological sample taken from the body.
- Analysis Method: The device uses "chemically treated membranes" and a "reflectance photometer" to produce a color change and measure analytes, which are typical methods for in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The BioScanner Plus (CardioChek brand) analyzer is intended to be used by healthcare professionals to measure blood analytes on a test strip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood 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 mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
Product codes (comma separated list FDA assigned to the subject device)
CHH, LBR, JGY
Device Description
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 membrane and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus (CardioChek brand) reflectance photometer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance: The test strips used for the new CLIA Waiver application gave better precision than those used in the original CLIA precision study. The improved precision performance is the basis of this Special 510(k). This improvement in precision was due to the scale-up of the process to manufacture larger lots of the test strips and the increase in manufacturing experience in producing this product. Once the product was manufactured on a larger scale, the precision (as measured by lot homogeneity) improved. The precision improvement supported changing the homogeneity testing acceptance criteria from 15% to 10% CV.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
SEP 2 4 2002
510(k) SUMMARY
CO22898 This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.
-
- Application Date:
August 29, 2002
- Application Date:
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
-
- Trade Names:
PTS PANELS Lipid Panel Test Strips
- Trade Names:
4. Description:
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 membrane and react to produce a color change. The Lipid Panel Test Strips are for in vitro diagnostic use with the BioScanner Plus (CardioChek brand) reflectance photometer.
5. Classification Names:
Cholesterol test system Lipoprotein test system Panel: Clinical Chemistry 75 Product Codes: CHH, LBR, JGY
6. Facility Address:
7736 Zionsville Road Indianapolis, IN 46268
Device Classification: 7.
Class I (Regulation: 21 CFR 862.1475, 862.1175, 862.1705)
8. Intended Use:
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) 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.
1
- Reason for 510(k): 9.
Device Modification
10. Predicate Device Information
The predicate devices for determination of substantial equivalence is: Name: PTS PANELS Lipid Panel Test Strips Device Company: Polymer Technology Systems. 510(k) Number: K013173
Similarities and Differences between the Lipid Panel Test Strip as presented in the original Special 510(k) and the Lipid Panel Test Strip that is the subject of this submission:
Similarities
- The test strip is the same. There are no differences in chemical . formulation, processes or design.
- . The test strip is used on the same unmodified instrument.
- The intended use is the same. .
Differences
Performance: The test strips used for the new CLIA Waiver application gave better precision than those used in the original CLIA precision study. The improved precision performance is the basis of this Special 510(k). This improvement in precision was due to the scale-up of the process to manufacture larger lots of the test strips and the increase in manufacturing experience in producing this product. Once the product was manufactured on a larger scale, the precision (as measured by lot homogeneity) improved. The precision improvement supported changing the homogeneity testing acceptance criteria from 15% to 10% CV.
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- Compliance with Special Controls
Does not apply.
- Compliance with Special Controls
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person with outstretched arms. The logo is black and white and appears to be a seal or emblem.
Public Health Service
SEP 2 4 2002
ood and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
Re: K022898
Trade/Device Name: Lipid Panel Test Strips Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) Test System Regulatory Class: Class I Product Code: CHH, LBR, JGY Dated: August 29, 2002 Received: September 3, 2002
Dear Mr. Enright:
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 (OS) 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 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 advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsmaldsmamain.html".
Sincerely yours,
Steven Butman
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
4
I) Sheer fand Drago Administration - Genter for Deviace and Radiological Health
Page 1 of
K022898 510(k) Number (if known):
Device Name:
Lipid Panel Test Strips
Indications for Use:
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The BioScanner Plus (CardioChek brand) analyzer is intended to be used by healthcare professionals to measure blood analytes on a test strip. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood 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 mellius, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.
(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K022898
prescription use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)