The Revised C-Reactive Protein Calibrator for the Dimension® Clinical Chemistry System is a device intended to calibrate the Dimension® clinical chemistry system for the Revised C-Reactive Protein (RCRP) method.

Device Description

The Dimension® Revised C-Reactive Protein Calibrator is a liquid product. Level 1 contains bovine serum albumin. Levels 2-5 contain human serum base product with added human C-Reactive Protein. The kit consists of ten vials; two at each of five levels.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical or performance study for a diagnostic device.

The document is a 510(k) summary for a calibrator device, not a diagnostic test kit that measures patient analytes directly. For calibrators, the primary focus for substantial equivalence is its intended use, composition, and its ability to properly calibrate the associated analytical system. The "performance" of a calibrator is typically demonstrated through its ability to provide accurate and reproducible calibration curves for the method it's designed to calibrate, rather than through sensitivity, specificity, or predictive values against a ground truth for a disease state.

Here's an attempt to answer your questions based on the limited information provided for this specific type of device submission:

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

Based on the provided document, the "acceptance criteria" for a calibrator device are primarily related to its intended use, composition, and ability to serve its purpose as a calibrator compared to a predicate device. There are no quantitative performance metrics (like accuracy, sensitivity, specificity) typically associated with diagnostic tests.

Acceptance Criteria (Inferred from Substantial Equivalence Comparison)	Reported Device Performance (Dimension® Revised C-Reactive Protein Calibrator)
Intended Use: Used as a calibrator for C-Reactive Protein.	Intended to be used to calibrate the Revised C-Reactive Protein (RCRP) method.
Analytes: C-Reactive Protein (CRP).	Contains C-Reactive Protein (CRP).
Matrix: Human serum base (for relevant levels).	Levels 2-5 contain human serum base.
Reference Standard: Traceable to IFCC CRM 470.	Traceable to IFCC CRM 470 (Primary standard).
Form: Liquid.	Liquid product.
Volume: 1.0 mL per vial.	1.0 mL per vial.
Levels: Sufficient levels for calibration (typically 2 or more).	5 levels.

2. Sample size used for the test set and the data provenance

Not applicable in the context of a calibrator device's 510(k) submission. There is no "test set" of patient samples in the way a diagnostic device would have for performance evaluation. The substantial equivalence is based on comparison of specifications and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no concept of "ground truth" established by experts for a calibrator itself. The ground truth for the analyte's concentration (C-Reactive Protein) is established by the primary reference standard (IFCC CRM 470) to which the calibrator is traceable.

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

Not applicable. No test set requiring adjudication is mentioned.

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

Not applicable. This is a calibrator, not a device involving human readers or AI assistance.

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

Not applicable. This is a calibrator, not an algorithm.

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

The "ground truth" for the concentration of C-Reactive Protein within the calibrator is established by its traceability to a primary standard, specifically IFCC CRM 470. This is a certified reference material, which serves as the highest-level ground truth for the concentration of the analyte.

8. The sample size for the training set

Not applicable. A calibrator device does not involve a training set as would a machine learning algorithm. Its values are determined during manufacturing and validated for consistency and traceability.

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

Not applicable. There is no training set mentioned for this device. The ground truth for the calibrator's analyte concentration is established by traceability to the IFCC CRM 470 primary standard.

Summary

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4/16/99

DADE BEHR

DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714

Summary of Safety and Effectiveness Information

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Submitter's Name:	Lorraine PiestrakDade Behring Inc.P.O. Box 6101Newark, DE 19714-6101
Date of Preparation:	March 11, 1999
Name of Product:	Dimension® Revised C-Reactive Protein Calibrato
FDA Classification Name:	Calibrator
Predicate Device:	Dade Behring N CRP Standard SY, K962406

Device Description: The Dimension® Revised C-Reactive Protein Calibrator is a liquid product. Level 1 contains bovine serum albumin. Levels 2-5 contain human serum base product with added human C-Reactive Protein. The kit consists of ten vials; two at each of five levels.

Intended use: The Dimension® Revised C-Reactive Protein Calibrator is intended to be used to calibrate the Revised C-Reactive Protein (RCRP) method on the Dimension® clinical chemistry system.

Comparison to Predicate Device:

Item	N CRP Standard SY	Revised C-Reactive Protein Calibrator
Intended Use	Calibrator	Calibrator
AnalytesMatrix	C-Reactive Protein (CRP)human serum base	C-Reactive Protein (CRP)L-1: bovine serum albuminL 2-5: human serum base
Form	lyophilized	liquid
Volume	0.5 mL per vial, reconstituted	1.0 mL per vial
Levels	1 levels	5 levels
Reference	Primary standard --IFCC CRM 470	Primary standard --IFCC CRM 470

Comments on Substantial Equivalence: Both the N CRP Standard SY and the Dimension® Revised C-Reactive Protein Calibrator are intended to be used as calibrators for C-Reactive Protein.

Conclusion: The Revised C-Reactive Protein Calibrator is substantially equivalent to the N CRP Standard SY based on the comparison discussed above.

Lorraine Piestrak

Quality Assurance and Compliance Manager March 11, 1999

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APR 1 6 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lorraine Piestrak Quality Assurance and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101

Re: K990824

Trade Name: Dimension® Revised C-Reactive Protein Calibrator Regulatory Class: I Product Code: JIT Dated: March 11, 1999 Received: March 12, 1999

Dear Ms. Piestrak:

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 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). 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 (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 requirements, 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.

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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 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"(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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Dutman

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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Indications For Use Statement

Device Name: Revised C-Reactive Protein Calibrator

Indications for Use:

ﺳﻤﻪ

ﺮ

Lorraine Pustiak

Lorraine Piestrak Quality Assurance and Compliance Manager

March 11, 1999

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ketu E. Maher

-Prescription Use (Per 21 CFR 801.109)

Over-the-counter Use_ ___________

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.