Roche CRP T Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentraion levels in quantitative C-reactive protein (CRP) assays. It is recommended for use with Roche reagents on COBAS® chemistry systems.

Roche CRP T Control N is part of a C-reactive protein immunological test system, which is 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.

Device Description

Roche CRP T Control N is part of a C-reactive protein immunological test system, which is used to measure, by immunochemical techniques, the C-reactive protein in serum and other body fluids.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided 510(k) summary for the "Roche® CRP T Control N" device, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study for a diagnostic device.

This device is a control product, meaning its purpose is to monitor the accuracy and precision of quantitative C-reactive protein (CRP) assays. It is not a diagnostic device itself that directly measures a patient's CRP level or diagnoses a condition. Therefore, the "study" and "acceptance criteria" for such a product are typically focused on its manufacturing specifications, stability, and its ability to consistently produce expected values within a defined range when run on an assay.

The 510(k) process for control products often relies heavily on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive new clinical performance studies.

Here's how the requested information maps to the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Expected Value Range)	Reported Device Performance (Mean	Standard Deviation)
3.44 - 4.66 mg/L (Concentration Range for Roche CRP T Control N)	Not explicitly stated as "reported device performance" in the context of meeting acceptance criteria, but this is the defined range for the control.
Comments: The document does not present a table of specific acceptance criteria met by a study. Instead, it provides the concentration range for the Roche CRP T Control N (3.44 - 4.66 mg/L), which serves as its defining characteristic and what it's expected to deliver when used. The comparison to the predicate device also lists concentration ranges. The concept of "acceptance criteria" for this device revolves around its ability to consistently fall within this specified range when tested, ensuring it functions as a reliable control.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable / Not provided. The document explicitly states: "No clinical or nonclinical tests were performed for this product."
Data Provenance: Not applicable, as no tests were performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable / Not provided. Since no clinical or nonclinical tests were performed, there was no "test set" requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable / Not provided. No test set was used that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This is a control product for a C-reactive protein assay, not an AI-assisted diagnostic device. The concept of "human readers" and "AI assistance" is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: No. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable / Not provided. No clinical or nonclinical tests were performed requiring a ground truth determination. For control products, the "ground truth" often refers to the highly accurate and validated "assigned values" or "target ranges" established during manufacturing and characterized by reference methods. While the document provides a "Concentration Range," it doesn't detail how this range was established with respect to a "ground truth" source in a study context.

8. The sample size for the training set

Training Set Sample Size: Not applicable / Not provided. This is not a machine learning or algorithm-based device that would require a training set.

9. How the ground truth for the training set was established

Ground Truth Establishment for Training Set: Not applicable / Not provided. No training set was used.

Summary of Approach in the Document:

The document primarily relies on substantial equivalence to a previously cleared predicate device ("Behring Diagnostics N/T Rheumatology Control SL 1 / 2"). The key comparison points are:

Matrix/Biological Sources: Both are "Liquid human serum."
Concentration Range: Roche CRP T Control N has a range of 3.44 - 4.66 mg/L, which is compared to the two levels of the predicate (Level 1: 9.0 - 12.2 mg/L and Level 2: 40.3 - 54.5 mg/L). While the ranges are different, this is acceptable for controls as long as they are manufactured to specific, consistent target values. The critical aspect is that they are both human serum-based controls for CRP assays.

The statement "No clinical or nonclinical tests were performed for this product" signifies that Roche is asserting that the device's function as a control product is sufficiently demonstrated by its similarity to the predicate and its manufacturing specifications, without the need for additional performance studies as typically required for primary diagnostic devices. The FDA's clearance letter confirms their acceptance of this approach for substantial equivalence.

Summary

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AUG 1 8 1998

KG82087

Image /page/0/Picture/2 description: The image shows the logo for Roche, a healthcare company. The logo consists of the word "Roche" in bold, sans-serif font, centered within a hexagon. The hexagon is outlined in black, and the word "Roche" is also in black.

510(k) Summary

Roche® CRP T Control N

In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.

The assigned 510(k) number is: K982087

I. Identification of 510(k) Sponsor:

Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

510(k) Submission dated: June 12, 1998

Contact: Rita Smith Senior Regulatory Affairs Associate Phone: (908) 253-7545 Fax: (908) 253-7547

Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

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II. Device Name:

The device name, including both the trade/proprietary name and the classification name are provided in the table below.

Table I

Product Name	ClassificationName	ProductCode	CFRNumber andRegulatory Class
RocheCRP T Control N	C-reactive protein, antigen,antiserum and control	DCK	866.5270Class II

Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:

The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.

Table 2

Product Name	Predicate ProductName	DatePredicateCleared	Predicate510(k)Number
RocheCRP T Control N	Behring DiagnosticsN/T Rheumatology Control SL 1 / 2	7/11/96	K962373

IV. Description of the Device/Statement of Intended Use:

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Summary of the technological characteristics of the new device in comparison to V. those of the predicate.

The Roche CRP T Control N and the Behringer N CRP Control are both human serum based controls with assayed values for C-reactive protein and intended for use in monitoring accuracy and precision in quantitative C-reactive protein (CRP) assays.

	Roche CRP T Control N	Behring DiagnosticsN/T Rheumatology Control SL 1/ 2
Matrix/Biological Sources	Liquid human serum	Liquid human serum
Concentration Range (mg/L)	3.44 - 4.66	Level 1	Level 2
		9.0 - 12.2	40.3 - 54.5

VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:

No clinical or nonclinical tests were performed for this product.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

AUG 1 8 1998

Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic Systems, Inc. Hoffmann-La Roche, Inc. 1080 U.S. Hiqhway 202 Somerville, New Jersey 08876-3771

K982087 Re : Roche® CRP T Control N Trade Name: Requlatory Class: II · · Product Code: DCK Dated: June 12, 1998 Received: June 15, 1998

Dear Ms. Smith:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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, Druq, 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 requirements for annual registration, listing of devices, qood 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 affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. 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 any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 leqally 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" (21 CFR 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 at (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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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Page 1 of 1

510(k) Number (if known) $K983087

Roche CRP T Control N, Art. No. 07 6632 1 Device Name:

Indications for Use:

(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)

Peter E. Mayhew

(Divisor
Div
5

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).