(48 days)
Not Found
No
The device description details a standard immunoturbidimetric assay for measuring CRP, which relies on chemical reactions and turbidimetric detection, not AI/ML algorithms. The document explicitly states "Not Found" for mentions of AI, DNN, or ML, and there is no description of training or test sets, which are typical for AI/ML-based devices.
No.
This device is an in vitro diagnostic immunoassay that measures CRP levels in human samples to aid in diagnosis and risk assessment, not to treat or directly restore health.
Yes
The device quantitatively determines C-reactive protein (CRP) levels, which are used for the "detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury," and as an "aid in the assessment of the risk of future coronary heart disease," fitting the definition of a diagnostic device.
No
The device is a laboratory assay kit, which includes reagents and is used on automated clinical chemistry analyzers. This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The device analyzes human serum and plasma, which are biological specimens taken from the body.
- Purpose: The purpose is to measure a substance (CRP) in these specimens to aid in the diagnosis and evaluation of medical conditions (inflammatory disorders, infection, tissue injury, and risk of coronary heart disease). This is the core function of an IVD.
- Device Description: The description details a "latex particle-enhanced immunoturbidimetric test," which is a laboratory method used to analyze biological samples.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.
Product codes (comma separated list FDA assigned to the subject device)
NQD
Device Description
The CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the quantitative measurement of C-reactive protein in human serum or plasma. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically. The calibrator is the Calibrator for automated systems (C.f.a.s). Proteins; and the recommended control materials are CRP T Control N and Precinorm Protein.
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)
Method comparison was performed between this method and the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Measuring range: 0-20 mg/L without dilution, 0-300 mg/L with postdilution
- Lower Detection Limit: 0.1 mg/L
- Within-run precision (%CV): Control material: 0.9% at 3.3 mg/L, 0.7% at 8.0 mg/L; Human serum: 1.3% at 1.6 mg/L, 0.6% at 11.4 mg/L
- Between-run precision (%CV): Control material: 3.5% at 3.3 mg/L, 2.2% at 8.0 mg/L; Human serum: 3.1% at 1.5 mg/L, 2.3% at 11.4 mg/L
- Functional Sensitivity (CV
§ 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
K 053603
FEB 9 2006
510(k) Summary
| 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
9115 Hague Road
Indianapolis, IN 46250
317-521-3723 |
| | Contact Person: Theresa M. Ambrose
Date Prepared: January 18, 2006 |
| Device Name | Proprietary name: C-Reactive Protein (Latex) High Sensitive test system for
COBAS Integra instruments [CRP (latex) HS]
Common name: hsCRP test system |
| | Classification name: Cardiac C-reactive Protein, Antigen, Antiserum, and
Control |
| Predicate
devices | The CRP (latex) HS Test System for COBAS Integra instruments is
substantially equivalent to the currently marketed Roche Tina-quant® CRP
(latex) HS Test System cleared under K042485. For purposes of cardiac risk
assessment, the CRP (latex) HS system is also equivalent to the Dade Behring
N High Sensitivity CRP (K033908) |
| Device
Description | The CRP (latex) HS Test System is a latex particle-enhanced
immunoturbidimetric test for the quantitative measurement of C-reactive
protein in human serum or plasma. Human CRP agglutinates with latex
particles coated with monoclonal anti-CRP antibodies. The precipitate is
determined turbidimetrically. The calibrator is the Calibrator for automated
systems (C.f.a.s). Proteins; and the recommended control materials are CRP T
Control N and Precinorm Protein. |
1
510(k) Summary, Continued
| Intended use | The CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome. |
|---|---|
| Comparison to predicate device | The below table compares the CRP (Latex) HS for COBAS Integra instruments with the predicate device, Tina-Quant® CRP (Latex) HS (K042485) |
2
510(k) Summary, Continued
Substantial eq
| Substantial equivalence: comparison table | |||
|---|---|---|---|
| Characteristic | CRP (Latex) HS for COBAS | ||
| Integra instruments | Predicate device | ||
| Tina-Quant® CRP (Latex) HS | |||
| (K042485) | Predicate device | ||
| Intended Use/ | |||
| Indications for | |||
| Use | Same as K042485 | The Tina-quant® CRP (Latex) High | |
| Sensitive Immmunoturbidimetric assay is | |||
| for the in vitro quantitative determination | |||
| of C-reactive protein (CRP) in human | |||
| serum and plasma on Roche automated | |||
| clinical chemistry analyzers. Highly | |||
| sensitive measurement of CRP is of use | |||
| for the detection and evaluation of | |||
| inflammatory disorders and associated | |||
| diseases, infection and tissue injury. | |||
| Measurement of CRP may also be used | |||
| as an aid in the assessment of the risk of | |||
| future coronary heart disease. When used | |||
| as an adjunct to other laboratory | |||
| evaluation methods of acute coronary | |||
| syndromes, it may also be an additional | |||
| independent indicator of recurrent event | |||
| prognosis in patients with stable | |||
| coronary disease or acute coronary | |||
| syndrome.. | N High Sensitivity CRP is an in vitro | ||
| diagnostic reagent for the quantitative | |||
| determination of C-reactive protein | |||
| (CRP) in human serum, and heparin and | |||
| EDTA plasma by means of particle- | |||
| enhanced immunonephelometry using | |||
| BN Systems. 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. | |||
| Measurements may also be used as an aid | |||
| in the identification of individuals at risk | |||
| for future cardiovascular disease. High | |||
| sensitivity CRP (hsCRP) measurements, | |||
| when used in conjunction with traditional | |||
| clinical laboratory evaluation of acute | |||
| coronary syndromes, may be useful as an | |||
| independent marker of prognosis for | |||
| recurrent events, in patients with stable | |||
| coronary disease or acute coronary | |||
| syndromes | |||
| Characteristic | CRP (Latex) HS for COBAS Integra instruments | Predicate device | |
| Tina-Quant® CRP (Latex) HS (K042485) | Predicate device | ||
| Dade-Behring N High Sensitivity CRP (K033908) | |||
| Assay principle | Same as K042485 | Latex particle-enhanced immunoturbidimetric test | Particle-enhanced agglutination with nephelometric detection |
| Instrument | COBAS Integra family of analyzers (Integra 400/ 700/ 800) | Roche/Hitachi family of analyzers | Dade-Behring BN Systems (nepholometric systems) |
| Reagent | |||
| Stability | Unopened kit: up to the stated expiration date at 2-8 °C On board the analyzer (opened and refrigerated): 12 weeks | Unopened kit: up to the stated expiration date at 2-8 °C On board the analyzer (opened and refrigerated): 90 days | Unopened kit: up to the stated expiration date at 2-8 °C Opened: 4 weeks at stored in closed vial. Do not freeze |
| Reagent | |||
| composition | Same active ingredients and antibody as K042485 | R1: TRIS buffer with bovine serum albumin, immunoglobulins (mouse), preservative, stabilizers | |
| R2: Latex particles coated with anti-CRP (mouse) in glycine buffer; preservatives; stabilizers | Suspension of polystyrene particles coated with mouse monoclonal antibodies to CRP; preservatives | ||
| Sample type | Same as K042485 | Human serum and plasma | Human serum, and heparin and EDTA plasma |
| Traceability/ | |||
| standardization | Standardized to Tina-Quant® CRP (Latex) HS which is standardized to reference preparation CRM 470 (RPPHS 91/0619) (same as both predicates) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) |
| Characteristic | CRP (Latex) HS for COBAS | ||
| Integra instruments | Predicate device | ||
| Tina-Quant® CRP (Latex) HS | |||
| (K042485) | Predicate device | ||
| Dade-Behring N High Sensitivity | |||
| CRP (K033908) | |||
| Measuring | |||
| range | 0-20 mg/L without dilution | ||
| 0-300 mg/L with postdilution | 0.1 – 20 mg/L without dilution | ||
| 0.1 – 300 mg/L extended range with | |||
| dilution and rerun | 0.175 – 1100 mg/L with dilution | ||
| Lower | |||
| Detection Limit | 0.1 mg/L | 0.03 mg/L | 0.175 mg/L |
| Within-run | |||
| precision | |||
| (%CV) | Control material | ||
| • 0.9% at 3.3 mg/L | |||
| • 0.7% at 8.0 mg/L | |||
| Human serum | |||
| • 1.3% at 1.6 mg/L | |||
| • 0.6% at 11.4 mg/L | Control material | ||
| • 0.43% at 4.27 mg/L | |||
| • 0.41% at 11.62 mg/L | |||
| Human serum | |||
| • 1.34% at 0.55 mg/L | |||
| • 0.28% at 12.36 mg/L | Control material | ||
| • 2.5% at 0.5 mg/L | |||
| • 3.8% at 1.3 mg/L | |||
| • 2.1% at 2.1 mg/L | |||
| • 2.6% at 14 mg/L | |||
| • 3.9% at 24 mg/L | |||
| • 5.7% at 56 mg/L | |||
| Between-run | |||
| precision | |||
| (%CV) | Control material | ||
| • 3.5% at 3.3 mg/L | |||
| • 2.2% at 8.0 mg/L | |||
| Human serum | |||
| • 3.1% at 1.5 mg/L | |||
| • 2.3% at 11.4 mg/L | Control material | ||
| • 2.70% at 4.34 mg/L | |||
| • 3.45% at 11.90 mg/L | |||
| Human serum | |||
| • 5.70% at 0.52 mg/L | |||
| • 2.51% at 10.98 mg/L | Control material | ||
| • 3.1% at 0.5 mg/L | |||
| • 3.8% at 1.1 mg/L | |||
| • 3.4% at 2.1 mg/L | |||
| • 4.0% at 15 mg/L | |||
| • 2.3% at 26 mg/L | |||
| • 4.4% at 62 mg/L | |||
| Characteristic | CRP (Latex) HS for COBAS Integra instruments | Predicate device Tina-Quant® CRP (Latex) HS (K042485) | Predicate device Dade-Behring N High Sensitivity CRP (K033908) |
| Functional Sensitivity (CV 5mg/L (lipemia; intralipid) | |||
| • L index of 800 at CRP > 4mg/L | |||
| • L index of 500 at CRP > 2 mg/L | |||
| • Rheumatoid factors 3.0 mg/L | |||
| For CVD risk assessment: relative risk | |||
| Low 3.0 mg/L | |||
| Comparison | y = Integra CRP (Latex) hs | ||
| x = Tina-Quant® CRP (latex) hs | y= Integra CRP (latex) hs | ||
| x= Dade-Behring N High Sensitivity CRP | |||
| Passing-Bablok results: y=1.0548x + 0.0424. T = 0.956; r = 0.996 |
he new test system has imilar interferes, comparable standards and alibrators, an
comparable in absolute values, which are cleared for indications including cariat
sk assess nalytical validation experiments were performed in order to establish the performance characteristics
ethod comparison was performed between this method and the predicate dev Performance
evaluation
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Theresa M. Ambrose Regulatory Principal Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250
FEB & 2006
Re: K053603
Trade/Device Name: C-Reactive Protein (Latex) High Sensitive Test System For Cobas Integra Instruments Regulation Number: 21 CFR8866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: December 22, 2005
Received: December 23, 2005
Dear Ms. Ambrose:
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 (OS) regulation (21 CFR Part 820).
9
Page 2 -
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known): K053603
Device Name: C-Reactive Protein (Latex) High Sensitive Test System For Cobas Integra Instruments
Indications For Use:
The CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Ann Chappell
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k)_ lc 053603