(112 days)
For in vitro diagnostic use only. The Drew Scientific Glycated Hemoglobin Five Level Linearity Kit is intended to verify the linearity of HbA1c assays across the patient reportable range (4 to 18%, NGSP aligned) using protocols established in individual laboratories.
Not Found
This document does not contain the information required to describe the acceptance criteria, device performance, or details of a study proving the device meets acceptance criteria.
The provided text is a 510(k) clearance letter from the FDA for a device called "Drew Scientific, Glycated Hemoglobin Five Level Linearity Kit." This letter grants marketing authorization based on a finding of "substantial equivalence" to a predicate device. It is not a study report or a detailed technical submission.
The letter explicitly states:
- "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..."
- "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."
Therefore, the document does not provide any of the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results or effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as an FDA clearance notice, not a performance study.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned above a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 19 2006
Miss. Diane Hill R&D Biochemist Drew Scientific Sowerby Woods Industrial Estate, Park Road Barrow-in-Furness, Cumbria LA14 4QR United Kingdom
Re: K060510
Trade/Device Name: Drew Scientific, Glycated Hemoglobin Five Level Linearity Kit Regulation Number: 21 CFR§862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: May 30, 2006 Received: June 2, 2006
Dear Miss. Hill:
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 iddications 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, Trug, 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 1.0 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 drivire, can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. EDA 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 aft 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 Party 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 logally marketed predicate device results in a classification for your device and thus, recruits 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 tollefree mober (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto G. A.
Alberto Gutierrez, Ph.D. 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: | K060510 |
|---|---|
| Device Name: | Drew Scientific,Glycated Hemoglobin Five Level Linearity Kit. |
| Indications For Use: | For in vitro diagnostic use only. The Drew ScientificGlycated Hemoglobin Five Level Linearity Kit is intended toverify the linearity of HbA1c assays across the patientreportable range (4 to 18%, NGSP aligned) using protocolsestablished in individual laboratories. |
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)
Caul C. Boun
Division Sign-Off
Page 1 of ___________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.