(84 days)
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Uses:
The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Here's an analysis of the provided text regarding the AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA device, focusing on acceptance criteria and study data:
Acceptance Criteria and Device Performance
The provided document is a 510(k) clearance letter from the FDA, which primarily confirms substantial equivalence to a predicate device. It does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance metrics (e.g., actual sensitivity and specificity percentages) from internal validation studies.
The "Indications For Use" section describes the intended use of the device, which implicitly defines the performance characteristics it must demonstrate to be deemed safe and effective.
Here's a breakdown of what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from "Indications for Use") | Reported Device Performance (Not explicitly detailed in this document) |
|---|---|
| Aid in the diagnosis of Coeliac Disease. | The FDA deemed the device substantially equivalent to a legally marketed predicate, implying its performance meets acceptable standards for its intended use. |
| Semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum. | The device performs this function. |
| Validation for use with the HYCOR HY.TEC automated EIA instrument. | This validation was successfully completed. |
| For in vitro diagnostic use only. | The device is intended for in vitro diagnostic use. |
Important Note: The FDA's 510(k) clearance process focuses on substantial equivalence. Detailed performance data, including specific sensitivity, specificity, accuracy, and precision with corresponding statistical analysis, would have been submitted by the manufacturer in their 510(k) application. This document is the outcome of that review, not the detailed performance report itself. Therefore, the specific numerical performance metrics are not available in this particular FDA letter.
2. Sample size used for the test set and the data provenance:
- Not specified in this document. The FDA letter does not include details on the sample size used for validation studies.
- Data Provenance: Not specified in this document. The country of origin for the data or whether it was retrospective or prospective is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in this document. The FDA letter does not detail the methodologies for establishing ground truth in the manufacturer's studies.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified in this document. The document does not provide details on how discrepancies in ground truth establishment were resolved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is an Enzyme-Linked Immunosorbent Assay (ELISA), which is a laboratory test, not an imaging device or AI-assisted diagnostic tool that would involve human "readers" or "interpreters" in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but not explicitly detailed as "standalone AI performance." As an ELISA, the device's performance is inherently "standalone" in the sense that the test results are generated by the assay itself without real-time human interpretation in the way an imaging AI works. The document states it's validated for use with an automated EIA instrument, suggesting it operates without direct human intervention once initiated. However, the exact performance metrics of this "standalone" (algorithm-only) aspect are not provided in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in this document. For a diagnostic test like this, ground truth for Coeliac Disease diagnosis would typically involve a combination of clinical assessment, endoscopy with duodenal biopsy showing characteristic pathology, and resolution of symptoms on a gluten-free diet. The specific methods used in the manufacturer's studies are not detailed here.
8. The sample size for the training set:
- Not applicable/Not specified. ELISA devices are not "trained" in the same way machine learning models are. They are biochemical assays developed and optimized based on chemical principles and validation studies, rather than using a "training set" to learn patterns.
9. How the ground truth for the training set was established:
- Not applicable. As explained above, the concept of a "training set" and associated ground truth establishment for AI/ML purposes does not directly apply to the development of an ELISA assay. The development involves optimization of reagents, reaction conditions, and calibration, which are different processes.
In summary: The provided FDA 510(k) clearance letter confirms the device's substantial equivalence and intended use. However, it does not contain the detailed technical specifications or study results (like sample sizes, expert qualifications, specific performance metrics, or ground truth methodologies) that would typically be found in the manufacturer's full 510(k) submission or a peer-reviewed publication.
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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 & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 7 - 2005
Hycor Biomedical Ltd. c/o Ms. Danielle M. Knight Pentlands Science Park Bush Loan Penicuik EH26 OPL United Kingdom
Re: K043433
K043433
Trade/Device Name: AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA
Trade/Device Name: AUTOSTATTM II Regulation Number: 21 CFR 866.5660 Regulation Name: 21 OF Resolution immunological test system Regulatory Class: Class II Product Code: MVM Dated: December 7, 2004 Received: December 15, 2004
Dear Ms. Knight:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premanted is substantially equivalent (for the indications for referenced above and nave actemined the are devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicants, or to devices that use stated in the enclosure) to tegally manited proadine and mondments, or to devices that pror to May 28, 1976, the enactinent date of the Federal Food. Of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the CPMA >> have been reclassified in accordance with the provisional application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application (Act (The yo Act (Act) that do not require approval of a provisions of the Act . The general therefore, market the device, subject to the general registration, list in the destices, good controls provisions of the netide requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in h If your device is classified (sec above) into enaler regulations affecting your device can be may be subject to such additions, 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 Please be advised that FDA s Issualice of a substance of a subcures with other requirement of the Act or that FDA has made a decemination mar your as router Federal agencies. You must comply with (21) CED Port 807) any Federal Statules and regulations administered by two registration and listing (21 CFR Parts of the availity all ine Act s requirements, including, but no rise requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice the since duat reading rea labeling (21 CFR Part 801), good manazati.net production the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050.
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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 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), please contact the Office of Compliance at (240) 276-3084. 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,
Robert J. Backerh.
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices 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): K043433
Device Name: AUTOSTAT™ II Anti-Tissue Transglutaminase IgG ELISA
Indications For Use:
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to tissue transglutaminase (tTg) in human serum.
Uses:
The results of the anti-fTg assay can be used as an aid in the diagnosis of Coeliac Disease. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
In addition to the manual assay protocol, this device has been validated for use with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.
ﮮ
Prescription Use Yes No (Part 21 CFR 801 Subpart D) Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnosti Device Evaluation and SCIES
510(k) K043453
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).