(86 days)
RaPET CRP (Class II) is intended for the qualitative and the semi-quantitative detection of C-Reactive Protein (CRP) in human serum. The latex slide test is intended to be used as an aid in evaluation of the amount of injury to body tissues.
The device test kit is comprised of CRP Latex Reagent, CRP Positive Control, Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.
The provided K974429 510(k) summary for RaPET® CRP includes information on the device's intended use and performance data. However, it does not explicitly define acceptance criteria as a separate table nor does it detail a study proving the device meets specific numerical acceptance criteria in the way a modern regulatory submission might. Instead, it demonstrates substantial equivalency to a predicate device.
Here's an attempt to structure the information based on your request, inferring what "acceptance criteria" might mean in the context of this 1998 submission, and highlighting where information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Inferred/Implicit) | Reported Device Performance |
|---|---|---|
| Method Comparison (Correlation to Predicate) | Strong correlation (implicit) | Correlation coefficient: 0.964, Regression equation: Y=0.93X + 0.36 (compared to Pulse's C-Reactive Protein Test) |
| Precision | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
| Sensitivity | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
| Specificity | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
| Interference Studies | Acceptable (implicit) | "Results of these tests were found to be acceptable." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the studies (method comparison, precision, sensitivity, specificity, interference).
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. Given the nature of a CRP latex agglutination test, ground truth would likely be established through quantitative laboratory methods, not expert visual assessment.
4. Adjudication method for the test set
- This information is not applicable/not provided. The assessment appears to be based on direct comparison to a predicate device and classical analytical performance studies, not opinion-based adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This information is not applicable/not provided. The RaPET® CRP is a laboratory assay kit, not an AI-assisted diagnostic imaging or human assessment tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not applicable/not provided. This is a manual latex agglutination test, not an algorithm. The "performance data" refers to the analytical performance of the kit itself.
7. The type of ground truth used
- The primary "ground truth" or reference method for the method comparison was a predicate device (Pulse's C-Reactive Protein Test).
- For precision, sensitivity, specificity, and interference studies, the ground truth would typically be established by controlled laboratory experiments and/or quantitative reference methods, but the specific details are not provided.
8. The sample size for the training set
- This information is not applicable/not provided. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable/not provided, as there is no training set for this type of device.
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510(k) Summary RaPET® CRP
FEB 1 8 1998
Tel. (210) 222-2108 Fax (210) 227-6367
Submitter's Name Kirk Johnson Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202
Prepared Bv Kirk Johnson November 14, 1997
Product Name Trade Name: RaPET® CRP Common Name: C-Reactive Test Classification Number: 82DCN
Description of Device
The device test kit is comprised of CRP Latex Reagent, CRP Positive Control, Negative Control and Glycine/Saline Buffer for performing semi-quantitative testing.
Intended Use of Device
RaPET® CRP is intended for the qualitative and semi-quantitative detection of C-Reactive Protein in human serum. The latex slide test is intended to be used as an aid in evaluation of the amount of injury to body tissues.
િંદર્ભ દિવસ
Comparison of Devices
Both NF latex methods employ latex beads coated with monospecific anti-human CRP (goat) which agglutinate in the presence of C-reactive protein serum.
Performance Data
Substantial equivalency was demonstrated by method comparison to Pulse's C-Reactive Protein Test. Correlation was performed between the two test kits with a correlation coefficient of 0.964 and a regression equation of Y=0.93X + 0.36.
In addition, precision, sensitivity, specificity, and interference studies were performed on RaPET® CRP. Results of these tests were found to be acceptable.
STA BORATORY, INC. 2930 Jston Stree San Antonio, Texas 78202
(210) 222-2108 1-800-531-5535 FAX (210) 227-6367
Image /page/0/Picture/21 description: The image shows a white logo on a black background. The logo appears to be a stylized letter 'S' or a spiral shape, with a circular element attached to the upper left. The overall design is simple and modern.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kirk Johnson Quality Assurance Manager Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202
FEB 1 8 1998
Re: K974429 Trade Name: RaPET® CRP Regulatory Class: II Product Code: DCN 82 November 19, 1997 Dated: Received: November 24, 1997
Dear Mr. Johnson:
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 reqistration, 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 (QS) 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. this response to your premarket notification Please note: 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 (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 Putman
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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Page 1 of 19
| 510(k) Number (if known): | K974429 |
|---|---|
| Device Name: | RaPET CRP |
Indications For Use:
RaPET CRP (Class II) is intended for the qualitative and the semi-quantitative detection of C-Reactive Protein (CRP) in human serum. The latex slide test is intended to be used as an aid in evaluation of the amount of injury to body tissues.
Peter E. Mduin
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 89744429
(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__________________________________________________________________________________________________________________________________________________________
- The state the
(Optional Format 1-2-96)
§ 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).