CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST
K972160 · Trinity Laboratories, Inc. · DCK · Aug 1, 1997 · Immunology
Device Facts
| Record ID | K972160 |
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| Device Name | CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE AGGLUTNATION LATEX TEST |
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| Applicant | Trinity Laboratories, Inc. |
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| Product Code | DCK · Immunology |
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| Decision Date | Aug 1, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 866.5270 |
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| Device Class | Class 2 |
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Intended Use
CRP-LEX-SYSTEM is intended to be used, in hospital and other The appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration. The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.
Device Story
CRP-LEX SYSTEM is an in vitro diagnostic device for detecting C-Reactive Protein (CRP) in human serum. It utilizes latex slide agglutination technology. The device consists of latex particles that agglutinate in the presence of CRP at concentrations at or above 8ug/ml (0.8mg/dl). It is intended for use in hospital and clinical laboratories by trained laboratory personnel. The procedure includes both a qualitative screening test and a semi-quantitative method involving serial dilution of patient specimens. Results are determined by visual observation of agglutination on a slide. The output assists clinicians in assessing CRP levels, which are markers for inflammation, aiding in clinical decision-making regarding patient inflammatory status.
Clinical Evidence
No clinical data provided; device relies on established latex slide agglutination methodology for CRP detection.
Technological Characteristics
Latex slide agglutination assay. Reagent consists of latex particles sensitized to detect CRP. Qualitative and semi-quantitative manual procedure. No electronic components, software, or energy sources required.
Indications for Use
Indicated for detection of C-Reactive Protein (CRP) levels in patient serum specimens in clinical laboratory settings. Used for qualitative screening and semi-quantitative assessment of CRP concentrations at or above 8ug/ml (0.8mg/dl).
Regulatory Classification
Identification
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
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Submission Summary (Full Text)
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Bruce A. Clinton, Ph.D. President Trinity Laboratories, Inc. 7517 Precision Drive Suite 107 Raleigh, NC 27613
AUG - 1 1997
Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re: Re K972160 Trade Name: CRP-LEX™ SYSTEM A Latex To Detect C-Reactive Protein In Serum Regulatory Class: II Product Code: DCK Dated: June 02, 1997 Received: June 09, 1997
Dear Dr. Clinton:
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 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 misbrynding 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices. General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (IDA) 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 affects 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 (770)488-7655,
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
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 (if known): Presently applied for
Device Name: CRP-LEXTM SYSTEM
Indications For Use:
CRP-LEX-SYSTEM is intended to be used, in hospital and other The appropriate clinical laboratories, to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration.
The CRP-LEX method is by latex slide agglutination. At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed. A screening (qualitative) and semi-quantitative procedure (dilution of the patient specimen) has been included and described.
Cuta E. Mapin
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K972160
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
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