(111 days)
PTS PANELS LDL Cholesterol Test Strips are intended to measure low density lipoprotein. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This system is intended for professional use.
Dry (Test Strip)
The provided text does not contain detailed acceptance criteria or a study description with the specific information requested in the prompt. The document is primarily a 510(k) summary for a medical device (PTS PANELS LDL Cholesterol Test Strips), focusing on its substantial equivalence to a predicate device.
It includes:
- Contact information for the submitter.
- Trade/common names, product code, and device classification.
- A comparison of the new device with a predicate device (Roche LDL-C Plus) regarding their intended use, test principle, sample requirements, and differences in sample type, form, and instrumentation.
- An FDA letter confirming the substantial equivalence determination and allowing marketing of the device.
- Indications for Use for the PTS PANELS LDL Cholesterol Test Strips.
However, the document does not provide:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- Information on any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Details about a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- The sample size for the training set.
- How the ground truth for the training set was established.
The document states that the new device shares the "Intended Use" with the predicate device: "Direct quantitative determination of LDL Cholesterol," and mentions that lipoprotein measurements are used in the "diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This describes the clinical utility but not specific performance metrics or acceptance criteria for the device itself.
To provide the requested information, a different type of document, such as a detailed study report, clinical trial results, or a specific section of the 510(k) submission detailing analytical and clinical performance data, would be needed.
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SECTION E: 510(k) SUMMARY
This summary of safety and effectiveness information is submitted in compliance with 21CFR 807.92.
March 12, 2004
Submitter 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
Trade Name: PTS PANELS LDL Cholesterol Test Strips
Common Name: Lipoprotein test system
Panel: Clinical Chemistry 75
Product Code: MRR
Device Classification: Class I
PTS PANELS LDL Cholesterol Test Strips are classified as a Class I device under Clinical Chemistry Systems - Lipoprotein Test System, 21CFR 862.1475.
Predicate Device Information
STATEMENT OF SUBSTANTIAL EQUIVALENCE
Polymer Technology Systems, Inc., intends to introduce into commercial distribution the PTS PANELS LDL Cholesterol Test Strips for the quantitative determination of LDL cholesterol in human whole blood. PTS PANELS LDL Cholesterol Test Strips are substantially equivalent to the predicate device noted below.
Name: Device Company: 510(k) Number:
LDL-C Plus Roche Diagnostics K974733
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Similarities and Differences (Predicate and New Device)
.
| Item | Predicate- Roche LDL-C Plus(K974733) | New Device- PTS PANELSLDL Cholesterol Test Strip |
|---|---|---|
| Intended Use | Direct quantitative determinationof LDL Cholesterol | Same |
| Test Principle | Colorimetric enzymatic assayusing surfactants as inhibitors ofnon-LDL | Same |
| Sample Requirements | Fasting and non-fasting | Same |
Differences
| Item | Predicate- Roche LDL-C Plus | New Device- PTS PANELSLDL Cholesterol Test Strip |
|---|---|---|
| Sample Type | Serum or Heparinized Plasma | Whole Blood (Fingerstick andEDTA and HeparinizedVenous) |
| Form | Wet (Liquid) | Dry (Test Strip) |
| InstrumentationRequired | Absorbance Photometer | Reflectance Photometer |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it, topped with a pair of wings.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL - 6 2004
Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
Re: K040693 Trade/Device Name: PTS PANELS LDL Cholesterol Test Strips Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: MRR Dated: June 21, 2004 Received: June 22, 2004
Dear Ms. 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 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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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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Jann M. Cooper, US, DVM.
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): K040693
Device Name: PTS PANELS LDL Cholesterol Test Strips
Indications For Use:
PTS PANELS LDL Cholesterol Test Strips are intended to measure low density lipoprotein. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
This system is intended for professional use.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
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)
Carol C. Benson
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Se
510(k) K040693
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§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.