QUANTA LITE INTRINSIC FACTOR ELISA by INOVA DIAGNOSTICS, INC.

The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "QUANTA Lite™ Intrinsic Factor ELISA" device. It does not contain information about acceptance criteria, a specific study, or detailed performance metrics. The document only specifies the device name, its indications for use, and confirms its substantial equivalence to a legally marketed predicate device.

Therefore, I cannot provide the requested information from this document. It lacks data on:

Acceptance criteria and reported device performance: No such table is present.
Sample size and data provenance: Not mentioned.
Number and qualifications of experts for ground truth: Not mentioned.
Adjudication method for the test set: Not mentioned.
MRMC comparative effectiveness study or effect size: Not applicable as this is an in-vitro diagnostic test, not an AI-assisted imaging device.
Standalone performance (algorithm only): Not applicable as this is an ELISA kit.
Type of ground truth used: Not specified.
Sample size for the training set: Not mentioned.
How ground truth for the training set was established: Not mentioned.

Summary

{0}------------------------------------------------

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 2006

INOVA Diagnostics, Inc. c/o Gary L. Norman, Ph.D. 9900 Old Grove Road Senior Scientist San Diego, CA 92131-1638

DEC 2 2006

Re: K061841

Trade/Device Name: QUANTA Lite™ Intrinsic Factor ELISA Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 Test System Regulatory Class: Class II Product Code: LIG Radioassay, intrinsic factor blocking antibody Dated: June 22, 2006 Received: June 29, 2006

Dear Dr. Norman:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

Page 2 –

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance 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 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 Becker Jr

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K061841

Device Name:_QUANTA Lite™ Intrinsic Factor ELISA

Indications for Use:

Prescription Use X (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)

Robert Becker
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061841

Page 1 of

Regulation Number and Section

§ 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.