Ouantex CRP High Sensitivity is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of C-Reactive Protein (CRP) in human serum on Clinical Chemistry Systems. C-Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.

Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.

Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.

Device Description

When a sample containing CRP is mixed with the Latex Reagent and the Reaction Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates.

Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.

Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.

AI/ML Overview

The quantex CRP High Sensitivity device is an in vitro diagnostic assay for the quantitative determination of C-Reactive Protein (CRP) in human serum. This summary describes the acceptance criteria and the study that demonstrates the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Although explicit "acceptance criteria" are not formally presented as thresholds in the provided text, the study aims to demonstrate substantial equivalence to a predicate device. Therefore, the performance metrics for comparison are derived from the observed results of the method comparison and precision studies. The implicit acceptance criteria are that the device's performance should be similar to or better than the predicate device and show acceptable precision for diagnostic use.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (quantex CRP High Sensitivity)
Method Comparison (vs. Predicate Device)
ILab 900/1800 System
Slope	Close to 1.0	0.948
Intercept	Close to 0	-0.105
Correlation Coefficient (r)	Close to 1.0 (indicating strong correlation)	0.9969
ILab 600 System
Slope	Close to 1.0	0.957
Intercept	Close to 0	-0.074
Correlation Coefficient (r)	Close to 1.0 (indicating strong correlation)	0.9989
Precision (Within-run CV%)
ILab 900/1800 System
Control 1 (2.39 mg/L CRP)	Low CV% (indicating high precision)	1.25%
Control 2 (5.87 mg/L CRP)	Low CV% (indicating high precision)	0.88%
ILab 600 System
Control 1 (2.32 mg/L CRP)	Low CV% (indicating high precision)	2.11%
Control 2 (5.82 mg/L CRP)	Low CV% (indicating high precision)	1.96%
Precision (Total CV%)
ILab 900/1800 System
Control 1 (2.39 mg/L CRP)	Low CV% (indicating high precision)	3.32%
Control 2 (5.87 mg/L CRP)	Low CV% (indicating high precision)	1.50%
ILab 600 System
Control 1 (2.32 mg/L CRP)	Low CV% (indicating high precision)	2.50%
Control 2 (5.82 mg/L CRP)	Low CV% (indicating high precision)	2.09%

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set:
- ILab 900/1800: 156 samples
- ILab 600: 55 samples
Data Provenance: The document does not explicitly state the country of origin for the samples or whether the study was retrospective or prospective. It is implied to be clinical samples used for method comparison on laboratory instruments.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the method comparison appears to be the results obtained from the predicate device (N High Sensitivity CRP).

4. Adjudication Method for the Test Set

No adjudication method is described, as the ground truth is based on the predicate device's measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or described. This device is an in vitro diagnostic assay, not an imaging or interpretation device that would typically involve human readers.

6. Standalone Performance Study

The performance data presented for "quantex CRP High Sensitivity" are standalone in the sense that they represent the algorithm's (or assay's) performance in determining CRP levels, independent of human interpretation beyond typical laboratory procedures. The method comparison specifically evaluates the device's results against those of a predicate device, which can be considered a form of standalone evaluation against a gold standard (the predicate).

7. Type of Ground Truth Used

The ground truth used for the method comparison study was the measurements obtained from the predicate device (N High Sensitivity CRP). For the precision studies, the 'ground truth' is the mean value of the controls (2.39 mg/L and 5.87 mg/L for ILab 900/1800; 2.32 mg/L and 5.82 mg/L for ILab 600), which are established values for quality control materials.

8. Sample Size for the Training Set

The provided document does not specify a separate "training set" or its sample size. For an in vitro diagnostic assay like this, development typically involves internal validation and optimization, but the document focuses on the performance studies for regulatory submission, which represent the "test set" or verification/validation data.

9. How Ground Truth for the Training Set Was Established

As no separate training set is explicitly mentioned or detailed in the document, the method for establishing its ground truth is not provided.

Summary

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103266 Section 3 quantex CRP High Sensitivity

510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4207 Fax:

Contact Person:

Carol Marble, Regulatory Affairs Director Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

August 27, 2003

Name of the Device:

quantex CRP High Sensitivity quantex CRP High Sensitivity standard multipoint quantex CRP High Sensitivity controls 1/2

Classification Name(s):

866.5270	C-Reactive Protein Immunological Test System	Class II
DCK	C-Reactive Protein, Antigen, Antiserum, and Control

Identification of predicate device(s):

K991385 N High Sensitivity CRP

Description of the device/intended use(s):

Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.

Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.

Statement of Technological Characteristics of the Device Compared to Predicate Device:

quantex CRP High Sensitivity is substantially equivalent to the commercially available predicate device (N High Sensitivity CRP) in performance and intended use.

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Section 3 (Cont.) quantex CRP High Sensitivity 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In method comparison studies evaluating 156 samples with CRP levels ranging from 0.18 to 283 mg/L on an ILab 900/1800 and 55 samples ranging from 0.20 to 283 mg/L on an ILab 600, the slope and correlation coefficient (r) for quantex CRP High Sensitivity versus the predicate device are shown below:

IL System	Slope	Intercept	r
ILab 900/1800	0.948	-0.105	0.9969
ILab 600	0.957	-0.074	0.9989

Precision

Within run precision assessed over multiple runs using two levels of control with the following results:

ILab 900/1800	Meanmg/L CRP	Within runCV%	TotalCV%
quantex CRP High Sensitivity control 1	2.39	1.25	3.32
quantex CRP High Sensitivity control 2	5.87	0.88	1.50
	Mean	Within run	Total
ILab 600	mg/dL CRP	CV%	CV%
quantex CRP High Sensitivity control 1	2.32	2.11	2.50
quantex CRP High Sensitivity control 2	5.82	1.96	2.09

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, with three curved lines forming the body and head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 9 2003

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421-3125

K032663 Trade/Device Name: quantex CRP High Sensitivity Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK: JIS; JIS; JJX Dated: November 21, 2003 Received: November 24, 2003

Dear Ms. Marble:

Re:

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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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,

Steven Butman

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): K032663

Device Name: quantex CRP High Sensitivity

Indications for Use:

Quantex CRP High Sensitivity standard multipoint is intended for use in establishing the calibration for the quantex CRP High Sensitivity reagents by turbidimetry.

Quantex CRP High Sensitivity controls 1/2 are intended for use in monitoring the quality control of results obtained with quantex CRP High Sensitivity reagents by turbidimetry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)	K032663
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Prescription Use(Per 21 CFR 801.019)		OR	Over-The-Counter Use
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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).