QUANTA LITE INTRINSIC FACTOR ELISA

K061841 · Inova Diagnostics, Inc. · LIG · Dec 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061841
• Device Name: QUANTA LITE INTRINSIC FACTOR ELISA
• Applicant: Inova Diagnostics, Inc.
• Product Code: LIG · Clinical Chemistry
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

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 Story

QUANTA Lite™ Intrinsic Factor ELISA is an in vitro diagnostic test for human serum samples. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect intrinsic factor antibodies. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The assay provides semi-quantitative results, which are interpreted by healthcare providers alongside clinical symptoms and other diagnostic tests to support the diagnosis of pernicious anemia. The device assists in identifying autoimmune-mediated vitamin B12 deficiency.

Clinical Evidence

No clinical data provided in the document; the submission relies on the device's performance as an ELISA for the detection of intrinsic factor antibodies.

Technological Characteristics

Polystyrene microwell ELISA plate coated with recombinant human intrinsic factor; goat anti-human IgG horseradish peroxidase conjugate; TMB chromogen; stop solution. Semi-quantitative spectrophotometric measurement at 450nm/620nm. Serum matrix. Manual/automated plate reader required.

Indications for Use

Indicated for the semi-quantitative detection of IgG class Intrinsic Factor antibodies in human serum to aid in the diagnosis of pernicious anemia. For prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 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 [phone]. 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 [phone] or [phone] 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

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## Indications for Use

510(k) Number (if known): k061841

Device Name:_QUANTA Lite™ Intrinsic Factor ELISA

Indications for Use:

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.

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

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