(133 days)
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.
An enzyme linked immunoassay (ELISA)
This FDA 510(k) clearance letter for the ImmuLisa Intrinsic Factor Antibody ELISA does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and study design. The document is primarily an approval letter, not a full summary of the performance study.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided document. The 510(k) clearance letter confirms that the device was deemed substantially equivalent to a predicate device, but it does not detail specific acceptance criteria (e.g., sensitivity, specificity thresholds) or the exact performance metrics reported in the submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. For an ELISA test, the "ground truth" would typically come from a reference method or clinical diagnosis based on a combination of factors, not necessarily based on expert interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. Adjudication methods are more relevant for subjective interpretations (e.g., radiology reads) than for quantitative ELISA results.
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
This information is not applicable and not available in the provided document. The ImmuLisa Intrinsic Factor Antibody ELISA is an in-vitro diagnostic (IVD) test, not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC study and
AI-assisted improvement metrics are irrelevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable in the provided document in the way it's framed. The device is a laboratory assay. Its performance is inherent to the assay procedure and relies on laboratory technicians performing the test correctly. There isn't an "algorithm only" component in the sense of a software-driven interpretation without human interaction typically found in AI devices. The "standalone" performance would be the analytical performance of the ELISA system itself (e.g., its sensitivity, specificity, accuracy against a reference method). These specific analytical performance metrics are not detailed in the clearance letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an ELISA diagnostic test like this, the ground truth for evaluating its performance would typically be based on:
- Clinical diagnosis of pernicious anemia: This would involve a comprehensive clinical assessment (e.g., B12 levels, clinical symptoms, other lab tests).
- Reference method/gold standard for intrinsic factor antibody detection: This might involve a different, already validated, and often more complex assay for intrinsic factor antibodies.
The specific type of ground truth used is not detailed in the provided document.
8. The sample size for the training set
This information is not available in the provided document. For an ELISA kit, "training set" is not typically a concept used in the same way as machine learning. Instead, there would be studies for assay development, optimization, and validation, but these wouldn't be referred to as a "training set" in the context you're asking.
9. How the ground truth for the training set was established
This information is not applicable and not available in the provided document. See the explanation for point 8.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
IMMCO Diagnostics, Inc. c/o Mr. Kevin Lawson Director of Regulatory Affairs 60 Pineview Drive Buffalo, NY 14228-2120
SEP 2 4 2007
Re: K071346
Trade/Device Name: ImmuLisa Intrinsic Factor Antibody ELISA Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: Class II Product Code: LIG Dated: September 04, 2007 Received: September 05, 2007
Dear Mr. Lawson:
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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
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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 (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Becker
Robert L. Becker, Jr., M.D., Ph.D. 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):
510(k) Number (if known):
Device Name:
ImmuLisa Intrinsic Factor Antibody ELISA
Indications For Use:
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Maria M Chan
Jivision Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.