LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965

K992252 · Chemicon Intl., Inc. · LYF · Aug 10, 1999 · Microbiology

Device Facts

• Record ID: K992252
• Device Name: LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
• Applicant: Chemicon Intl., Inc.
• Product Code: LYF · Microbiology
• Decision Date: Aug 10, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3780
• Device Class: Class 2

Indications for Use

The Light Diagnostics Pneumocystis carinii DFA intended use is an in vitro procedure for the detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens including sputum, bronchoaveolar lavage, and lung biopsy.

Device Story

Light Diagnostics Pneumocystis carinii DFA is an in vitro diagnostic test for identifying Pneumocystis carinii in respiratory specimens. The device utilizes direct immunofluorescence (DFA) to detect cysts and trophozoites in clinical samples. Used in clinical laboratory settings by trained laboratory personnel. The output is a visual result observed via fluorescence microscopy, aiding clinicians in the diagnosis of Pneumocystis carinii pneumonia. The test provides rapid identification, facilitating timely clinical decision-making and patient management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

In vitro diagnostic reagent kit utilizing direct immunofluorescence (DFA) technology for the detection of Pneumocystis carinii. The device is a standalone diagnostic assay intended for professional laboratory use.

Indications for Use

Indicated for the detection of Pneumocystis carinii cysts and trophozoites in respiratory tract specimens (sputum, bronchoalveolar lavage, lung biopsy) for in vitro diagnostic use.

Regulatory Classification

Identification

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 10 1999

Ms. Cindy D. Penny Ouality Assurance Manager Chemicon International, Inc. 28835 Single Oak Drive Temecula. California 92590

Re: K992252

Trade Name: Light Diagnostics Pneumocystis carinii DFA Regulatory Class: II Product Code: LYF Dated: July 26, 1999 Received: July 27, 1999

Dear Ms. Penny:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number

Device Name

Light Diagnostics Pneumocystis carinii DFA

Indications for Use

The Light Diagnostics Pneumocystis carinii DFA intended use is an in vitro procedure for the detection of Pneumocystis carinii cysts and trophozoites in direct smears of respiratory tract specimens including sputum, bronchoaveolar lavage, and lung biopsy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <i>Woody Dubals</i> |
|---------------|-----------------------------------------|
| | (Division Sign Off) |
| | Division of Clinical Laboratory Devices |
| 510(k) Number | K992252 |

| Prescription Use | X | OR | Over-The-Counter-Use | |
|----------------------|---|----|----------------------|--|
| (Per 21 CFR 801.109) | | | | |