(38 days)
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay systems within the clinical range.
The provided text describes the 510(k) summary for Good Biotech Corp.'s CRPex CRP Controls, intended for use as an assayed quality control material for serum C-reactive protein (CRP) analysis. It focuses on demonstrating substantial equivalence to a predicate device, Roche CRP T Control N.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria in this context are primarily demonstrating substantial equivalence to a predicate device by showing comparable characteristics. The "performance" is implicitly the C-reactive protein concentration range.
| Acceptance Criteria | Reported Device Performance (CRPex CRP Controls) | Predicate Device (Roche CRP T Control N) |
|---|---|---|
| Matrix/Biological Sources: Must be comparable to predicate. | Liquid human serum | Liquid human serum |
| Concentration Range (mg/L): Must provide appropriate control levels for CRP analysis. | Level L: 1.28 – 1.92 Level M: 4.54 – 6.81 Level H: 46.82 – 70.23 | Level M: 3.44 – 4.66 (Specific ranges for L and H levels of the predicate are not explicitly stated, but the overall purpose is to show comparable function and suitable ranges for quality control) |
Note: While the exact "acceptance criteria" for the concentration ranges aren't explicitly stated as numerical targets that were met, the submission implies that these ranges are deemed acceptable for the intended use and demonstrate equivalence to the predicate control.
2. Sample Sizes Used for the Test Set and Data Provenance
This document does not provide information on sample sizes used for a test set or data provenance for performance studies. As a quality control material, the "study" typically involves determining the assigned values and stability of the control, rather than a diagnostic performance study on patient samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For a quality control material, "ground truth" would typically refer to the accurately assigned values of CRP within the control, established through rigorous analytical methods and reference materials, rather than expert consensus on diagnostic images or clinical data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods are relevant for studies involving human interpretation or multi-reader scenarios, which are not applicable to the evaluation of a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This document does not mention an MRMC comparative effectiveness study. MRMC studies are typically conducted for diagnostic devices (e.g., imaging AI) where human readers interpret cases with and without AI assistance. This is not applicable to a CRP control material.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable to the given device. The CRPex CRP Controls are a material used to assess the performance of other assay systems, not a standalone diagnostic algorithm. The "performance" of the controls themselves relates to their stability, homogeneity, and accurately assigned values, which are evaluated through analytical methods.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" refers to the assigned C-reactive protein concentrations within the various control levels (L, M, H). This would be established through:
- Quantitative analytical methods: Using a reference method or a highly accurate clinical analyzer calibrated against certified reference materials.
- Traceability to international standards: Ensuring the assigned values are traceable to recognized CRP standards.
The document states that the controls have "assigned C-reactive protein concentration," indicating this type of ground truth was established.
8. Sample Size for the Training Set
This information is not provided. As a quality control material, there isn't a "training set" in the context of machine learning or AI. The development of the control involves formulation, testing for stability, homogeneity, and value assignment, not training an algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no "training set" in the context of this device. The ground truth (assigned CRP concentrations) for the control material itself would be established through analytical testing and value assignment protocols, as described in point 7.
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SEP 2 3 2002
510(k) Summary Safety and Effectiveness
"This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92."
| CRPex CRP Controls Level L, M, H | |
|---|---|
| Submitter | |
| Name, | Good Biotech Corp. |
| Address, | 38 34th Rd. Taichung Industrial Park Taichung City 407 TaiwanR.O.C. |
| Telephone number, | +886-4-23596873 |
| Contact person, | Victor Chiou |
| Preparation date | August 14, 2002 |
| Device | |
| Trade name, | CRPex CRP Controls Level L, M, H |
| Common name, | CRP Control Material |
| Classification name | C-reactive protein immunological test system (21CFR 866.5270) |
| Predicate Device | |
| Trade name, | Roche CRP T Control N |
| 510(k) number | K982087 |
| Description | |
| Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. Each CRP Control contains certain level of human serum CRP to assist in monitoring the precision and accuracy of assay |
systems within the clinical range.
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Measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Intended Use
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For in vitro diagnostic use.
Substantial
Equivalence
CRPex-HS CRP Controls and Roche CRP T Control N are both human serum based controls with assigned C-reactive protein concentration and intended for use in monitoring accuracy and precision in CRP analysis.
| Item\Device | CRPex CRP Controls | Roche CRP T Control N |
|---|---|---|
| Matrix/Biological Sources | Liquid human serum | Liquid human serum |
| Concentration Range(mg/L) | Level L1.28 – 1.92 | |
| Level M4.54 – 6.81 | 3.44 – 4.66 | |
| Level H46.82 – 70.23 |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of a bird-like figure. The bird-like figure is composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 3 2002
Mr. Victor Chiou President Good Biotech Corporation 38 34th Road Taichung Industrial Park 407 Taichung City, Taiwan, R.O.C.
K022725 Re:
Trade/Device Name: CRPex CRP Controls Level L, M, H Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed). Regulatory Class: Class I Product Code: JJX Dated: August 14, 2002 Received: August 16, 2002
Dear Mr. Chiou:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -
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 v 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrlvdsma/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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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K 033-725__
Device Name: CRPex CRP Controls Level L, M, H
Indications For Use:
Good Biotech Corp. CRPex CRP Controls are intended to be used as the assayed quality control material for serum C-reactive protein (CRP) analysis. For In Vitro Diagnostic Use.
(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)
ાર
Over-The-Counter Use __
(Optional Format 1-2-96)
J.P. Reeves Acting Branch Chief I/
of Clinical Laboratory I 510(k) Number -
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.