HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases,

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

Device Description

Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

The HS-CRP is a latex particle enhanced immunoturbidimetric assay to quantify CRP in When a plasma containing CRP is mixed with the Latex Reagent and the Reaction plasma. 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. The test range is well suited to cover apparent normality as well as the requirements as a marker of infectious and inflammatory diseases.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the HemosIL High Sensitivity - C Reactive Protein device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state formal "acceptance criteria" with numerical thresholds. Instead, it presents performance data in comparison to a predicate device and precision data. The implicit acceptance criterion is "substantial equivalence" to the predicate device.

Performance Metric	Implicit Acceptance Criteria (based on predicate equivalence and typical assay requirements)	Reported Device Performance (HemosIL High Sensitivity - C Reactive Protein)
Method Comparison (vs. Predicate Device)
Slope (ACL 9000)	Close to 1.0	0.972
Intercept (ACL 9000)	Close to 0.0	-0.070
Correlation Coefficient (r) (ACL 9000)	High (e.g., >0.95 or >0.97)	0.9950
Slope (ACL Futura)	Close to 1.0	0.942
Intercept (ACL Futura)	Close to 0.0	-0.027
Correlation Coefficient (r) (ACL Futura)	High (e.g., >0.95 or >0.97)	0.9945
Precision (Within Run CV%)
Low HS-CRP Control (ACL 9000)	Low (e.g., <5%)	1.75%
High HS-CRP Control (ACL 9000)	Low (e.g., <5%)	1.01%
Low HS-CRP Control (ACL Futura)	Low (e.g., <5%)	3.04%
High HS-CRP Control (ACL Futura)	Low (e.g., <5%)	3.42%
Precision (Total CV%)
Low HS-CRP Control (ACL 9000)	Low (e.g., <10%, ideally <5%)	2.57%
High HS-CRP Control (ACL 9000)	Low (e.g., <10%, ideally <5%)	1.50%
Low HS-CRP Control (ACL Futura)	Low (e.g., <10%, ideally <5%)	3.42%
High HS-CRP Control (ACL Futura)	Low (e.g., <10%, ideally <5%)	3.63%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 153 samples were used for the method comparison study. The sample size for the precision studies is not explicitly stated as a number of individual patient samples, but rather as "multiple runs using two levels of control."
Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is generally not applicable to an in vitro diagnostic (IVD) device like a CRP assay. The "ground truth" for the method comparison is the measurement obtained from the predicate device. For precision, the control material itself acts as the reference. Therefore, no external experts were used to establish ground truth in the way one might for diagnostic imaging or clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. As this is an IVD device measuring a biochemical marker, there is no expert adjudication process for the test results in the way there would be for subjective interpretations (e.g., radiology reads). The predicate device's readings are the reference.

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 an automated in vitro diagnostic assay, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented (method comparison and precision) represent the standalone performance of the HemosIL High Sensitivity - C Reactive Protein device. It is an automated system designed to provide quantitative results directly from plasma samples.

7. The Type of Ground Truth Used

For the method comparison study, the "ground truth" was established by the predicate device (N High Sensitivity CRP). The performance of the new device was compared to that of an already legally marketed and accepted device.
For the precision studies, the "ground truth" was represented by the assigned values of the control materials (Low HS-CRP Control and High HS-CRP Control). These controls typically have a known, target concentration of the analyte.

8. The Sample Size for the Training Set

Not applicable. This is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The device's performance is based on its chemical and optical characteristics, which are validated through analytical studies like those presented.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

Summary

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10232469

DEC 2 3 2002

Section 3 HemosIL High Sensitivity - C Reactive Protein 510(k) Summary (Summary of Safety and Effectiveness)

Submitted by:

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

Contact Person:

Carol Marble. Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207

Summary Prepared:

September 30, 2002

Name of the Device:

HemosIL High Sensitivity - C Reactive Protein, AND HemosIL High Sensitivity - C Reactive Protein Controls

Classification Name(s):

866.5270	C-Reactive Protein Immunological Test System	Class II
81DCK	C-Reactive Protein, Antigen, Antiserum, and Control

Identification of predicate device(s):

N High Sensitivity CRP K991385

Description of the device/intended use(s):

Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

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

HemosIL High Sensitivity - C Reactive Protein is substantially equivalent to the commercially available predicate device (N High Sensitivity CRP) in performance and intended use.

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Section 3 HemosIL High Sensitivity - C Reactive Protein 510(k) Summary (Summary of Safety and Effectiveness)

Summary of Performance Data:

Method Comparison

In method comparison studies evaluating 153 samples with CRP levels ranging from 0.18 to 258 mg/L on an ACL 9000 and an ACL Futura, the slopes and correlation coefficients (r) for HemosIL High Sensitivity -- C Reactive Protein versus the predicate device are shown below:

IL System	Slope	Intercept	r
ACL 9000	0.972	-0.070	0.9950
ACL Futura	0.942	-0.027	0.9945

Precision

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

ACL 9000	Meanmg/L CRP	Within runCV%	TotalCV%
Low HS-CRP Control	2.594	1.75	2.57
High HS-CRP Control	6.186	1.01	1.50
ACL Futura	Meanmg/dL CRP	Within runCV%	TotalCV%
Low HS-CRP Control	0.255	3.04	3.42
High HS-CRP Control	0.607	3.42	3.63

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that converge at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, MA 02421-3125

Re: K023269

Trade/Device Name: HemosIL High Sensitivity - C Reactive Protein AND HemosIL High Sensitivity - C Reactive Protein Controls Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: December 16, 2002 Received: December 17, 2002

Dear Ms. Marble:

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. Drue, 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). 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):

Device Name: HemosIL High Sensitivity - C Reactive Protein AND HemosIL High Sensitivity - C Reactive Protein Controls

Indications for Use:

HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.

Jean Coogh

(Division Sign-Off)
Division or Clinical Laboratory Devices
510(k) Number 6023269

(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 801.019)

Over-The-Counter Use
----------------------	--

High Sensitivity - C Reactive Protein 510(k)

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).