(46 days)
Not Found
No
The summary describes a standard immunoturbidimetric assay for CRP measurement, which is 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.
The device is an in vitro quantitative determination assay used for diagnostic purposes, not for treating diseases or conditions.
Yes
The device aids in detecting and evaluating inflammatory disorders, infections, tissue injury, and assessing the risk of coronary heart disease, which are all diagnostic purposes.
No
The device description clearly states it is a "latex particle-enhanced immunoturbidimetric test," which is a laboratory assay involving physical reagents and a clinical chemistry analyzer (hardware). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "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..."
The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism. The purpose of the device is to analyze biological samples (serum and plasma) to provide diagnostic information about a patient's health status (CRP levels for inflammatory disorders, infection, tissue injury, and coronary heart disease risk). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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. 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 Tina-quant® CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the measurement of C-reactive protein in human serum or plasma.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 2 9 2004
| 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: September 9, 2004 | |
| Device Name | Proprietary name: Tina-Quant CRP (Latex) HS Test System (C-reactive protein (latex) high sensitive) |
| Common name: hsCRP test system | |
| Classification name: Cardiac C-reactive Protein, Antigen, Antiserum, and Control | |
| Predicate device | The Tina-quant® CRP (latex) HS Test System is substantially equivalent to the currently marketed Roche Tina-quant® CRP (latex) HS Test System cleared under K003400. For purposes of the extended intended use, we claim equivalence to the currently marketed Dade Behring N High Sensitivity CRP (K033908) |
| Device Description | The Tina-quant® CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the measurement of C-reactive protein in human serum or plasma. |
1
510(k) Summary, Continued
Intended use 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. 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. The below table compares Tina-Quant® CRP (Latex) HS with the predicate Comparison to
predicate device
devices, Tina-Quant® CRP (Latex) HS (K003400), and Dade-Behring N High Sensitivity CRP (K033908).
2
510(k) Summary, Continue
Substantial equivalence, comparison table.
| Substantial equivalence: comparison table
Characteristic | Tina-Quant® CRP (Latex) HS
(modified intended use) | Predicate device
Tina-Quant® CRP (Latex) HS
(K003400) | Predicate device
Dade-Behring N High Sensitivity
CRP (K033908) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Intended Use | 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. | Immunoturbidimetric assay for the in
vitro quantitative determination of
CRP in human serum and plasma on
automated clinical chemistry analyzers. | 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 | Indications for Use | Predicate device
Tina-Quant® CRP (Latex) HS
(modified intended use) | Predicate device
Tina-Quant® CRP (Latex) HS
(K003400) | Predicate device
Dade-Behring N High Sensitivity
CRP (K033908) |
| Indications for
Use | 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 coronary heart disease.
When used as an adjunct to other
laboratory evaluation methods of
acute coronary syndromes, it may be
an additional independent indicator
of recurrent event prognosis in
patients with stable coronary disease
or acute coronary syndrome. | For the quantitative determination of
C-reactive protein in human serum and
plasma. 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. | 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 | |
| Assay principle | Same as K003400 | Latex particle-enhanced
immunoturbidimetric test | Particle-enhanced agglutination
with nephelometric detection | |
| Instrument | Same as K003400 | Roche/Hitachi family of analyzers | Dade-Behring BN Systems
(nepholometric systems) | |
| Reagent
Stability | | | | |
| Same as K003400 | | 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 | |
| Sample type | Same as K003400 | Human serum and plasma | Human serum, and heparin and EDTA plasma | |
| Traceability/
standardization | Same as both predicates | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | |
| Measuring
range | Same as K003400 | 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 | Same as K003400 | 0.03 mg/L | 0.175 mg/L | |
| Within-run
precision
(%CV) | Same as K003400 | 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 | 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) | Same as K003400 | 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 | 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 | |
| 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 | |
Continued on next page
28
3
510(k) Summary, Continued
Predicate device (continued
4
30
:
5
:
31
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
OCT 2 9 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Theresa M. Ambrose, Ph.D., DABCC, FACB, RAC Regulatory Principal Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
Re: K042485
Trade/Device Name: Tina-Ouant® CRP (Latex) HS Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: September 10, 2004 Received: September 13, 2004
Dear Dr. 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 (QS) regulation (21 CFR Part 820).
7
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 (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,
Jean M. Cooper, US, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): N/A K042485
510(k) Number (if known): N/A
Device Name: Tina-Quant® CRP (Latex) HS
Indications For Use:
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. 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 X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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) Page 1 of
Carol Benson
Division Sign-Off
of in Vitro Diaar
510(k). K02485
24