IMMULISA INTRINSIC FACTOR ANTIBODY ELISA

K071346 · Immco Diagnostics, Inc. · LIG · Sep 24, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071346
• Device Name: IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: LIG · Clinical Chemistry
• Decision Date: Sep 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The ImmuLisa™ Anti-Intrinsic Factor (IF) Antibody ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of antibodies to intrinsic factor in human serum to aid in the diagnosis of pernicious anemia.

Device Story

ImmuLisa Intrinsic Factor Antibody ELISA is an in vitro diagnostic test used to detect and semi-quantitate intrinsic factor antibodies in human serum samples. The device utilizes enzyme-linked immunosorbent assay (ELISA) technology to identify these antibodies, which are associated with pernicious anemia. The test is intended for use by clinical laboratory professionals to assist physicians in diagnosing patients suspected of having pernicious anemia. Results are provided to the clinician to support clinical decision-making regarding patient diagnosis and management.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Solid-phase ELISA. Components: polystyrene microwell plates coated with recombinant glycosylated human intrinsic factor, alkaline phosphatase-labeled goat anti-human IgG conjugate, pNPP substrate. Requires spectrophotometer (405nm/620nm). Qualitative/semi-quantitative output. Manual/automated plate reader workflow. No specific ASTM materials cited.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of anti-intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.

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

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 [phone]. 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 [phone] or [phone] 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)

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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

K071346