(165 days)
A C-reactive protein immunological test system us a device that consists of the reagents used to measure by immunologiyal techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protcin aids in evaluation of the amount of injury to body tissucs.
The Wako CRP Calibrator and Wako CRP Calibrator Sct are designed to be used with the Wako CRP test for the determination of the C-Reactive protein in serum.
The Wako CRP test is an in vitro assay for the quantitative determination of C-reactive protein in serum. When a sample is mixed with Buffer and Antibody, CRP in the sample combines specifically with anti-human CRP antibody (goat) in the Antibody to yield an insoluble aggregate that causes increased turbidity in the solution. The degree of turbidity of solution can be measured optically and is proportional to the concentration of CRP in the patient's sample.
The provided text is a 510(k) summary for the Wako CRP test, an in vitro assay for the quantitative determination of C-reactive protein in serum. It describes the intended use, principle of the method, and general performance characteristics like linearity and minimum detectable level. However, it does not explicitly provide a formal table of acceptance criteria or a detailed study section with specific data proving the device meets those criteria.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
The document hints at performance specifications but doesn't present them as formal acceptance criteria with corresponding study results in a table format.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Linearity (one-point calibration) | Linear up to 150 mg/L |
| Linearity (multi-point calibration) | Linear up to >250 mg/L (highest calibrator) Note: The text states "more than 250 mg/L," but later says "230 mg/L when using the Wako CRP Calibrator Set." This creates a slight ambiguity. |
| Linearity (single-point calibrator) | Linear to 200 mg/L |
| Minimum Detectable Level | Estimated to be 1 mg/L |
| Precision | Acceptable values can be obtained on a day-to-day basis |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test sets or the provenance (e.g., country of origin, retrospective/prospective) of the data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The Wako CRP test is an in vitro diagnostic device that measures a biomarker (CRP concentration) in serum. The "ground truth" for such a device is typically established by comparing its results to a recognized reference method or clinically validated samples with known CRP concentrations, not by expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable/not provided. Adjudication methods like 2+1 or 3+1 are common in studies involving expert interpretation of images or clinical cases, not typically for quantitative in vitro diagnostic assays measuring a biomarker.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are relevant for devices that are interpreted by human readers (e.g., AI in radiology). This device is a biochemical assay.
6. Standalone (Algorithm Only) Performance Study
Yes, the information provided describes the standalone performance of the Wako CRP test, as it is an in vitro diagnostic assay that produces quantitative results. The performance characteristics mentioned (linearity, minimum detectable level, precision) are inherent to the algorithm/assay itself, without human interpretation in the loop.
7. Type of Ground Truth Used
The "ground truth" for an in vitro diagnostic device like the Wako CRP test would be established by:
- Reference materials/calibrators with known CRP concentrations: Used to establish linearity and calibrate the assay.
- Comparison to a legally marketed predicate device or a clinical reference method: To demonstrate substantial equivalence and accuracy.
- Clinical samples with CRP levels determined by a validated method.
The document implies the use of calibrators (Wako CRP Calibrator and Wako CRP Calibrator Set) to establish linearity and for the determination of CRP.
8. Sample Size for the Training Set
The document does not explicitly state a sample size for a "training set." For an in vitro diagnostic assay, the development process involves extensive internal validation and optimization, which could be considered analogous to training, but it's not typically described in terms of a "training set" in the same way an AI/ML algorithm would. The calibrator sets mentioned are used for the actual calibration of the assay during use, not for an initial "training" of the device algorithm itself.
9. How Ground Truth for the Training Set Was Established
As above, the concept of a "training set" in the AI/ML sense doesn't directly apply here. The "ground truth" for the calibrators would be established through careful analytical methods to assign precise CRP values to them, often traceable to international reference standards. The document mentions the use of "Wako CRP Calibrator Set" and "Wako single point CRP Calibrator," implying these are used to define the quantitative response of the assay.
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KO24280
Wako Chemicals USA. Inc. 1600 Bellwood Road, Richmond, VA 23
510(K) Summary of Safety and Effectiveness
Intended use
The Wako CRP test is an in vitro assay for the quantitative determination of C-reactive protein in serum.
Summary and explanation of the test
A protein that binds the C-polysaccharide on the cell wall of Streptococcus pneumoniae presents in the sera of acutely ill patients. This protein is called C-reactive protein (CRP), which has been recognized as one of the acute phase reactants that rise dramatically in the case of inflammation or tissue destruction. Determination of CRP is clinically useful for detecting. inflammation and infections. Various methods can be used for the determination of CRP (e.g. turbidimetric immunoassay (TIA), nephelometric immunoassay (NIA) and latex immunoassay (LIA). The Wako CRP test is a highly specific reagent based on turbidimetric immunoassay. 12 The Wako CRP test with one -point calibration shows the linearity up to 150 mg/L. The Wako CRP test with multi-point calibrations shows the linearity up to the highest value of calibrator set (more than 250 mg/L).
Principle of the method
When a sample is mixed with Buffer and Antibody, CRP in the sample combines specifically with anti-human CRP antibody (goat) in the Antibody to yield an insoluble aggregate that causes increased turbidity in the solution. The degree of turbidity of solution can be measured optically and is proportional to the concentration of CRP in the patient's sample.
Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estimated to be 1 mg/L . The assay is lincar to 230 mg/L when using the Wako CRP Calibrator Sct and 200 mg/L when using the Wako single point CRP Calibrator.
References
Burtis, C. A. and Ashwood, E. R., Ed .: Tietz Textbook of Clinical Chemistry, 2nd Ed., Saunders, Philadelphia, 1994.
Lothar Thomas, M.D., Ed .: Clinical Laboratory Diagnostics
DG Klinische Chemic Mitteilungen 26 (1995) page5.
Tracy RP, Lemaltro RN, Peaty BM, Ives DG, Evans RW, Cushman M, Mellahn EN, Kuller LH, Rclationship of C-reactive protein to risk of cardiovascular disease in the elderly; results from the Cardiovascular Health Study and the Rural Hearth Promotion Project. Arterioscler Thrombo Vaso Biol, 1997; 17:1121-1127
Tuzallallum
Tonya Mallory Executive Manager
April 7, 2003
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 6 2003
Ms. Tonya Mallory Executive Manager Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
K024280 Re:
Trade/Device Name: Wako CRP, Wako CRP Calibrator and Wako CRP Calibrator Set Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK; JIT; JJX Dated: March 31, 2003 Received: April 1, 2003
Dear Ms. Mallorv:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 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 (301) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use:
A C-reactive protein immunological test system us a device that consists of the reagents used to measure by immunologiyal techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protcin aids in evaluation of the amount of injury to body tissucs.
The Wako CRP Calibrator and Wako CRP Calibrator Sct are designed to be used with the Wako CRP test for the determination of the C-Reactive protein in serum.
Proprietary Name: Wako CRP, Wako CRP Calibrator and Wako CRP Calibrator Set
| Establishment Registration Number: | 1627434 |
|---|---|
| Premarket Notification 510(k) Number: | K024280 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, ODE
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)
Sean Cooper
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 0.24280
§ 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).