The Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetric assay. Anti-CRP antibodies coupled to latex microparticles react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.

AI/ML Overview

The provided text is a 510(k) summary for the Tina-quant CRP (Latex) device. It describes the device's intended use, method, and comparison to a predicate device. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission for substantial equivalence to an existing device, and as such, it focuses on demonstrating that the new device is as safe and effective as the predicate device. It highlights similarities in intended use and methodology but also notes differences in measuring range and allowable plasma types. Crucially, it does not provide data from specific studies demonstrating performance against acceptance criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

A table of acceptance criteria and the reported device performance: This information is not present in the 510(k) summary.
Sample sizes used for the test set and the data provenance: Not detailed in the provided text.
Number of experts used to establish the ground truth for the test set and their qualifications: Not detailed in the provided text.
Adjudication method for the test set: Not detailed in the provided text.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, including effect size: Not detailed in the provided text. This type of study is more common for diagnostic imaging AI, not for a quantitative immunoassay like this.
If a standalone performance study was done: The document describes the device itself but doesn't provide details on specific performance studies (like accuracy, precision, or linearity studies that would typically be performed).
The type of ground truth used: Not detailed in the provided text.
The sample size for the training set: Not applicable as this is a chemical assay, not an AI/machine learning device that requires a "training set" in the conventional sense.
How the ground truth for the training set was established: Not applicable for the same reason as above.

The 510(k) summary focuses on establishing "substantial equivalence" to a predicate device (Roche Diagnostics Tina-quant CRP (Latex) HS assay, K003400) by comparing attributes like intended use, method, sample type, and measuring range. It explains that the modified device has an expanded measuring range compared to the predicate. The FDA's letter (pages 2-3) confirms the substantial equivalence determination but does not delve into the specific performance study details you are asking for.

Summary

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510(k) Summary - Tina-quant CRP (Latex)

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) 521-3831Contact person: Sherri L. CoenenDate prepared: July 25, 2003
Device Name	Proprietary name: Roche Diagnostics Tina-quant CRP (Latex)
	Common name: Tina-quant CRP (Latex)
	Classification name: C-reactive protein immunological test system
Devicedescription	The Tina-quant CRP (Latex) is a particle-enhanced immunoturbidimetricassay. Anti-CRP antibodies coupled to latex microparticles react with antigenin the sample to form an antigen/antibody complex which is measuredturbidimetrically.
Intended use	Immunoturbidimetric assay for the in vitro quantitative determination of CRPin human serum and plasma on automated clinical chemistry analyzers.
PredicateDevice	We claim substantial equivalence to the currently marketed RocheDiagnostics Tina-quant CRP (Latex) HS assay. (K003400).

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510(k) Summary - COBAS Integra Creatinine plus ver.2,

continued

The following table describes the similarities and differences between the Reagent : Summary Tina-quant CRP (Latex) and the predicate device.

Topic	Tina-quant CRP (Latex) HS(K003400)	Tina-quant CRP (Latex)(Modified Device)
Intended Use	Immunoturbidimetric assay for the invitro quantitative determination ofCRP in human serum and plasma onautomated clinical chemistryanalyzers.	Same
Method	Particle-enhancedimmunoturbidimetric assay	Same
Sample type	SerumPlasma: Li-/Na-heparin, Na-/K3-EDTA, citrate plasma	SerumPlasma: Li-/Na-heparin, Na-/K2-/K3-EDTA
Measuringrange	Roche/Hitachi 902:0.1 - 20 mg/L Roche/Hitachi904/911/912/917/Modular P:0.2 - 20 mg/L0.1 - 300 mg/L with rerun	Roche/Hitachi 902:1 - 265 mg/L Roche/Hitachi 717/Modular D:1 - 265 mg/L1 - 398 mg/L with rerun Roche/Hitachi 904/911/912:1 - 260 mg/L1 - 520 mg/L with rerun Roche/Hitachi 917/Modular P:1 - 280 mg/L1 - 560 mg/L with rerun
Expectedvalues	< 0.5 mg/dl	Same

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AUG - 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Sherri L Coenen, MT (ASCP) Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

Re: K032336
Trade/Device Name: Tina-quant CRP (Latex) Regulation Number: 21 CFR 866.5270 Regulation Name: C. reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: July 25, 2003 Received: July 29, 2003

Dear Ms. Coenen:

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).

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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). 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): N/A

Device Name: Tina-quant CRP (Latex)

Indications For Use:

Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers.

Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Prescription Use (Per 21 CFR 801.109)	Concurrence of CDRH, Office of Device Evaluation (ODE)
OR	Over-The-Counter Use

(Optional Format 1-2-96)

Division Sign-Off
	For Jean Cooper
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)	K032336

Regulation Number and Section

§ 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).