(190 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for C-reactive protein, a well-established laboratory technique that does not typically involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No.
Explanation: The device is an in vitro diagnostic assay used for the quantitative determination of C-reactive protein to detect and assess inflammatory disorders. It does not provide any therapy or treatment.
Yes
The device is used for the "detection and assessment of inflammatory disorders, tissue injury and infection," which are diagnostic purposes. The quantitative determination of C-reactive protein aids in diagnosing these conditions.
No
The device description explicitly states it is a "latex particle-enhanced immunoturbidimetric assay packaged for use on the Roche/Hitachi family of analyzers," indicating it is a physical assay kit and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of C-reactive protein in human serum and plasma." This involves testing biological samples in vitro (outside the body).
- Device Description: It describes a "latex particle-enhanced immunoturbidimetric assay." This is a laboratory-based test method performed on biological samples.
- Purpose: The purpose is to aid in the "detection and assessment of inflammatory disorders, tissue injury and infection" by measuring a substance in the blood. This is a diagnostic purpose.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DCN
Device Description
The C-Reactive Protein US test is a latex particle-enhanced immunoturbidimetric assay packaged for use on the Roche/Hitachi family of analyzers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the CRP US were evaluated and found to be equivalent to those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 576 3723
Contact person: Priscilla A Hamill
Date prepared: October 27, 2000 |
| Device Name | Proprietary name: CRP US Test System
Common name: C-Reactive Protein test
Classification name: System, Test, C-Reactive Protein |
| Device
description | The C-Reactive Protein US test is a latex particle-enhanced
immunoturbidimetric assay packaged for use on the Roche/Hitachi family of
analyzers. |
| Intended use | For the quantitative determination of C-reactive protein in human serum and
plasma. |
| Indication for
use | The C-reactive protein test is used for the detection and assessment of
inflammatory disorders, tissue injury and infection. |
| Substantial
equivalence | The CRP US test is equivalent to other devices legally marketed in the United
States. We claim equivalence to the Roche Integra C-Reactive Protein test
(K981897). |
1
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 Device
CRP US | Predicate Device
Roche Integra Cassette
(K981897) |
|--------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Intended use | For the quantitative determination
of C-reactive protein | For the 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) |
The following table compares the CRP US, with the predicate devices. Substantial equivalence differences
| Feature | New Device
CRP US | Predicate Device
Roche Integra Cassette
(K981897) |
|-----------------|-------------------------------------------------------|---------------------------------------------------------|
| Assay principle | Latex particle - enhanced
immunoturbidimetric test | Latex particle - enhanced
immunoturbidimetric test |
| Instrument | Roche/Hitachi family of
analyzers | 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
2
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.
3
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
4
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) |