The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.

Device Description

The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.

AI/ML Overview

The provided document is a 510(k) summary for the quantex ASO-CRP-RF control II device, which is an in vitro diagnostic product. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to establish new performance criteria. Therefore, several of the requested categories in your prompt are not directly applicable or fully elaborated in this type of regulatory submission.

Here's an analysis based on the information provided:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance (quantex ASO-CRP-RF control II)	Predicate Device Performance (quantex ASO-CRP-RF control)
Within-run precision (ASO) ≤ predicate %CV	2.7% %CV	4.8% %CV
Within-run precision (CRP) ≤ predicate %CV	1.6% %CV	3.5% %CV
Within-run precision (RF) ≤ predicate %CV	1.1% %CV	1.7% %CV
Substantial equivalence in performance, intended use, and safety and effectiveness to the predicate device.	Deemed substantially equivalent by FDA.	Established as legally marketed.

Note: The acceptance criteria are implicit as the submission's goal is to demonstrate that the new device is "substantially equivalent" to the predicate. The performance data provided show that the new device's within-run precision (%CV) is better than or equal to the predicate device, thereby meeting the unstated expectation of comparable or improved performance.

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

Sample size: Not explicitly stated. The study refers to "a comparative performance study," implying multiple measurements were taken to calculate the %CV, but the exact number of runs or replicates is not specified.
Data provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory setting by the manufacturer. It is a retrospective analysis of data generated during the device's development/validation.

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

This information is not applicable. The device is a quality control material, not a diagnostic device for which expert consensus on patient conditions would be required. The "ground truth" for a control material is its expected performance characteristics (e.g., precision), which are determined through statistical analysis of its own repeated measurements.

4. Adjudication method for the test set

Not applicable as explained above.

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 device is a quality control material for automated instruments, not an AI-assisted diagnostic tool.

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

The device itself is a standalone control material. Its performance (precision) was evaluated in a standalone manner on a COBAS Mira instrument. The evaluation did not involve a human-in-the-loop scenario.

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

The "ground truth" in this context is the intrinsic performance characteristics (specifically, within-run precision, expressed as %CV) of the control material itself, and the comparison of these characteristics to those of its predicate device, as measured on the intended automated instrumentation. It's an internal validation of a manufactured product's consistency.

8. The sample size for the training set

Not applicable. This is a quality control material, not an algorithm that requires a "training set."

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

Not applicable.

Summary

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1984437

FEB 2 1999

Section 3 quantex ASO-CRP-RF control II - 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Carol Marble Regulatory Affairs Manager Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 781-861-4464 Fax:

Contact Person:

Carol Marble Phone: 781-861-4467 / Fax: 781-861-4464

Summary Prepared:

December 11, 1998

Name of the device:

quantex ASO-CRP-RF control II

Classification name(s):

Quality Control Material (Assayed and Unassayed) Class I 862.1660

Identification of predicate devices:

quantex ASO-CRP-RF control K971777

Description of the device/intended use(s):

The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.

Statement of how the Technological Characteristics of the Device compare to the Predicate device:

The new quantex ASO-CRP-RF control II is substantially equivalent in performance, intended use and safety and effectiveness to the predicate control: quantex ASO-CRP-RF control.

Summary of Performance Data:

In a comparative performance study on a COBAS Mira, the new quantex ASO-CRP-RF control II exhibited excellent with-in run precision in comparison to the precise control. control 11 Exmoned excellent with in run %CV for the new control was 2.7% (ASO), 1.6% (CRP) and 1.1 (RF) as compared to with-in run %CV for the predicate control of 4.8% (ASO plus), 3.5% (CRP) and 1.7% (RF).

Section 3

quantex ASO-CRP-RF control II 510(k)

Page 1 of 1

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB | 2 1999

Carol Marble Regulatory Affairs Manager INSTRUMENTATION LABORATORY COMPANY 113 Hartwell Avenue Lexington, MA 02421

Re: K984437 Trade Name: quantex ASO-CRP-RF control II Requlatory Class: I Product Code: JJT December 11, 1998 Dated: December 14, 1998 Received:

Dear Ms. Marble:

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 aqainst 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 In addition, FDA may publish further regulatory action. 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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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 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 Putman

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

510(k) Number (if known): K984437

Device Name: quantex ASO-CRP-RF control II

Indications for Use:

The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.

Peter E. Machin
(Division Sign-Off)
Division of Clinical Laboratory Devices

(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)

OR Over-The-Counter Use _

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.