(102 days)
The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.
Fluorescent immunoassay reagents.
The provided text describes a 510(k) premarket notification for the Alfa Biotech (UK) Ltd AuraFlex® FT3, an immunoassay for free triiodothyronine. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Correlation of 0.9 with an "Other FT3 assay," with the specific linear relationship: AuraFlex® FT3 = 0.93 * (Other FT3 assay) + 0.2 pg/ml (or 0.3 pmol/l). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 110 human serum samples.
- Data Provenance: Not explicitly stated, but the submission is from Alfa Biotech (UK) Ltd, suggesting the study may have been conducted in the UK or with UK-sourced samples. The data type is retrospective as it refers to a "comparison study" that was "conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. The "ground truth" appears to be established by comparison to another existing FT3 assay, rather than expert consensus on individual samples.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study conducted was a comparison of a new immunoassay against an existing one, not a study involving human readers or AI assistance.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone study of the device (immunoassay) performance. There is no mention of human-in-the-loop performance or AI.
7. The Type of Ground Truth Used
The ground truth was established by comparison to the results of an "Other FT3 assay." This implies a reference method or legally marketed predicate device.
8. The Sample Size for the Training Set
This information is not provided in the given text. The text describes a "comparison study" of 110 samples, likely representing the test set for performance evaluation. There's no mention of a separate training set.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its ground truth was established is not applicable/not provided.
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510(k) Premarket Notification Alfa Biotech (UK) Ltd AuraFlex® FT3
10.0 510(K) SUMMARY
FEB - 2 1998
A 510(k) Summary follows for the AuraFlex® FT3 reagents described in this submission.
510(k) Summary AuraFlex® FT3
12.05.
This summary and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Submitter's Name: Alfa Biotech (UK) Ltd
Submitter's Address: Unit 4, Spring Lakes Estate, Deadbrook Lane, Aldershot, Hants, GU12 4UH
Submitter's Telephone: (44) 1252 341477
Submitter's Contact: Mr M John Taylor
Date 510(k) Summary Prepared: September 26, 1997
Device Trade or Proprietary Name: AuraFlex® FT3
Device Common or Usual Name: Immunoassay for free triiodothyronine
Device Classification Name: Free triiodothyronine Test System
Device Description: Fluorescent immunoassay reagents.
Device Intended Use: The AuraFlex® FT3 assay is a fluorescent immunoassay for the quantitative determination of free triiodothyronine assay in human serum or plasma using the AuraFlex® System.
Data Upon Which Substantial Equivalence was Determined:
A comparison study was conducted in which 110 human serum samples were assayed using the AuraFlex® FT3 assay in singlicate. Results between the two assays showed a correlation of 0.9 (AuraFlex* FT3 = 0.93 Other FT3 assay +0.2pg/ml (0.3 pmoV1).
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three heads, symbolizing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB - 2 1998
M. John Taylor . Director of Quality and Regulatory Affairs Alfa Biotech (UK) Ltd. 4 Spring Lakes Estate Deadbrook Lane Aldershot Hants GU12 4UH
Re : K974027 AuraFlex® FT3 Requlatory Class: II Product Code: CDP January 21, 1998 Dated: Received: January 21, 1998
Dear Mr. Taylor:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existinq major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ substantially equivalent determination assumes compliance with --the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
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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| 510(k) Number (if known): | K974027 |
|---|---|
| Device Name: | AURAFLEX FT3 |
Page ___ of ___Indications for Use:
AuraFlex FT3 employs a fluorescent enzyme immunometric assay technology for the quantitative determination of free triodothyronine (FT-) in human serum or plasma using the AuraFlex system.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use_ (Per 21 CFR 801. 109)
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Optional Format 1-2-96)
(Division Sign-Off)
Division of Clinical Laboratory Device
510(k) Number K974027
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.