(53 days)
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.
CRP-LEX™ SYSTEM A Latex To Detect C-Reactive Protein In Serum. The CRP-LEX method is by latex slide agglutination.
This document is a marketing authorization letter for the CRP-LEX™ SYSTEM, a device intended to detect C-Reactive Protein (CRP) in serum. It is not a study report, and therefore does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices. It states the "Indications For Use" which describe what the device is intended to do, but not the performance metrics of a specific study.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- Acceptance Criteria & Reported Performance: The document provides the intended use: "to detect CRP levels in patient serum specimens around the 8ug/ml (0.8mg/d1) concentration" and that "At CRP levels at or above this noted concentration, agglutination of the CRP-LEX, latex particles should be observed." This describes the functionality and threshold for detection, not specific performance metrics like sensitivity, specificity, accuracy, or their acceptance criteria from a validation study.
- Sample Sizes (Test & Training): Not mentioned in this regulatory letter.
- Data Provenance: Not mentioned.
- Number of Experts & Qualifications: Not mentioned.
- Adjudication Method: Not applicable for a device described in this type of letter.
- MRMC Comparative Effectiveness Study: Not mentioned, and generally not applicable for a diagnostic test like this unless comparing it to human readers interpreting raw data (which is not the case for a latex agglutination test).
- Standalone Performance: The described "CRP-LEX method is by latex slide agglutination." The performance of this method is inherent to the device itself. However, the details of its standalone performance (e.g., sensitivity, specificity values) are not provided.
- Type of Ground Truth: The device detects CRP levels. The "ground truth" for a device like this would typically be established by a reference method for CRP quantification, but this is not detailed in this regulatory letter.
- Ground Truth for Training Set: Not mentioned.
In summary, the provided document is a regulatory approval letter based on a 510(k) submission, confirming substantial equivalence. It does not provide the detailed study results and performance metrics that your request asks for. To find that information, one would typically need to consult the 510(k) summary, peer-reviewed publications, or the manufacturer's internal validation reports, which are not included here.
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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)
新浪漫画会演唱 蜜桃影院 | 1000 | 1
§ 866.5270 C-reactive protein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).