(190 days)
For the quantitative determination of C-reactive protein in human serum and plasma. The C-reactive protein test is used for the detection and assessment of inflammatory disorders, tissue injury and infection. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.
The C-Reactive Protein US test is a latex particle-enhanced immunoturbidimetric assay packaged for use on the Roche/Hitachi family of analyzers.
Here's an analysis of the provided 510(k) summary for the CRP US Test System based on your request. Please note that the document primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed information about a de novo study to establish new acceptance criteria and prove the device meets them from scratch. It relies on the predicate device's established performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in the format of a separate section with pass/fail thresholds. Instead, it demonstrates substantial equivalence by comparing features and stating that the performance characteristics were evaluated and found to be equivalent to the predicate device.
However, based on the context of a 510(k) submission, the implicit "acceptance criteria" for the new device (CRP US) are that its performance characteristics are comparable to the legally marketed predicate device (Roche Integra C-Reactive Protein test, K981897).
Therefore, the table below reflects this comparative performance rather than absolute acceptance criteria with specific numerical targets.
| Feature / Performance Characteristic | Acceptance Criteria (Implicit - Equivalent to Predicate) | Reported Device Performance (CRP US) |
|---|---|---|
| Intended Use | Quantitative determination of C-reactive protein | Quantitative determination of C-reactive protein |
| Indication for Use | Detection and assessment of inflammatory disorders, tissue injury and infection | Detection and assessment of inflammatory disorders, tissue injury and infection |
| Sample Type | Human serum and plasma | Human serum and plasma |
| Traceability | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) |
| Assay Principle | Latex particle-enhanced immunoturbidimetric test | Latex particle-enhanced immunoturbidimetric test |
| Instrument Platform | Integra family of analyzers | Roche/Hitachi family of analyzers (This is the primary difference identified) |
| Overall Performance | Equivalent to predicate device | Evaluated and found to be equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the specific data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "performance characteristics...evaluated" without providing specific study details.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The nature of the device (in-vitro diagnostic for C-Reactive Protein) typically involves analytical validation against reference methods or established standards rather than expert clinical consensus for "ground truth" in the same way an imaging AI algorithm might.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation (e.g., medical imaging) to resolve discrepancies among multiple readers. For an in-vitro diagnostic device like this, performance is assessed through analytical studies using laboratory methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist human readers in tasks like image interpretation, which is not the function of the CRP US Test System.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The device itself is a standalone in-vitro diagnostic test. Its performance is evaluated analytically, without a "human-in-the-loop" component in terms of result generation. The results are obtained directly from the analyzer.
7. The Type of Ground Truth Used
The "ground truth" for evaluating the performance of the CRP US Test System would implicitly involve comparison to:
* Reference materials/standards: The document mentions "IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619)" for traceability, indicating an objective, standardized basis for measurement.
* Predicate device results: A key aspect of a 510(k) submission is demonstrating equivalence to a legally marketed predicate. Therefore, the "ground truth" for proving substantial equivalence would largely be the established performance and results from the predicate device through comparative studies.
* Clinical correlation (implied): While not explicitly detailed, the clinical utility of CRP measurement for "detection and assessment of inflammatory disorders, tissue injury and infection" reflects that the results are expected to align with clinical outcomes or physician diagnoses, though this isn't the primary "ground truth" for analytical performance.
8. The Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning, as the CRP US Test System is a latex particle-enhanced immunoturbidimetric assay, not an AI/ML algorithm. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set was Established
As the device is not an AI/ML algorithm, the concept of a "training set" and establishing its ground truth in that context is not applicable here. The assay's performance is based on its biochemical and analytical principles.
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MAY 1 0 2001
510(k) Summary - CRP US on Roche / Hitachi Family of Clinical Analyzers
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence |
|---|---|
| Submittername, address,contact | Roche Diagnostics Corporation9115 Hague RdIndianapolis IN 46250(317) 576 3723Contact person: Priscilla A HamillDate prepared: October 27, 2000 |
| Device Name | Proprietary name: CRP US Test SystemCommon name: C-Reactive Protein testClassification name: System, Test, C-Reactive Protein |
| Devicedescription | The C-Reactive Protein US test is a latex particle-enhancedimmunoturbidimetric assay packaged for use on the Roche/Hitachi family ofanalyzers. |
| Intended use | For the quantitative determination of C-reactive protein in human serum andplasma. |
| Indication foruse | The C-reactive protein test is used for the detection and assessment ofinflammatory disorders, tissue injury and infection. |
| Substantialequivalence | The CRP US test is equivalent to other devices legally marketed in the UnitedStates. We claim equivalence to the Roche Integra C-Reactive Protein test(K981897). |
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510(k) Summary - CRP US on Roche / Hitachi Family of Clinical Analyzers, continued
The following table compares CRP US, with the predicate devices. Substantial equivalence similarities
| Feature | New DeviceCRP US | Predicate DeviceRoche Integra Cassette(K981897) |
|---|---|---|
| Intended use | For the quantitative determinationof C-reactive protein | For the quantitative determinationof C-reactive protein |
| Indication for use | Detection and assessment ofinflammatory disorders, tissueinjury and infection. | Detection and assessment ofinflammatory disorders, tissueinjury and infection. |
| Sample type | Human serum and plasma | Human serum and plasma |
| Traceability | IFCC/BCR/CAP referencepreparation CRM 470 (RPPHS91/0619) | IFCC/BCR/CAP referencepreparation CRM 470 (RPPHS91/0619) |
The following table compares the CRP US, with the predicate devices. Substantial equivalence differences
| Feature | New DeviceCRP US | Predicate DeviceRoche Integra Cassette(K981897) |
|---|---|---|
| Assay principle | Latex particle - enhancedimmunoturbidimetric test | Latex particle - enhancedimmunoturbidimetric test |
| Instrument | Roche/Hitachi family ofanalyzers | Integra family of analyzers |
The performance characteristics of the CRP US were evaluated and found to Substantial equivalence be equivalent to those of the predicate device. performance characteristics
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the wings of a bird. The caduceus is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
MAY 1 0 2001
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
510(k) Number: K003400 Re: Trade/Device Name: CRP HS Test System Regulation Number: 866.5270 Regulatory Class: II Product Code: DCN Dated: October 27, 2000 Received: November 1, 2000
Dear Ms. Hamill:
We have reviewed your Section 510(k) notification of intent to market the device referenced n o have level have determined the device is substantially equivalent 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 are is 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( remarket ripp. V ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perious on. 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 affect reeister. Frease now hight 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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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 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 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 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Ν/Δ Κορ3400
Device Name: CRP US Test System
Indications For Use:
For the quantitative determination of C-reactive protein in human seram and plasma. In For the quantitative determilation of Of a number of plasma proteins, including Cacute phase response, increased levels of a number of plasma proteins, and acure protein, are observed. Measurement of CRP is useful for the detection and reactive protein, are observed. Measuremont of Orders, and associated diseases.
evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.
Fred Lacy
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K003400 |
(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) |
§ 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).