Biokit's ASO-CRP-RF control 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 contains a known assayed value of antistreptolysin-O, C-reactive protein and rheumatoid factor, is mixed with the quantex ASO plus, quantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.

Device Description

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "quantex ASO-CRP-RF control."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on demonstrating "substantial equivalence" in performance to predicate devices, specifically in terms of within-run variance (%CV). While explicit numerical acceptance criteria values are not stated as "acceptance criteria," the reported performance demonstrates similarity to the predicate devices, which is the basis for substantial equivalence.

Analyte	Acceptance Criteria (Implied by Predicate Performance)	Reported Device Performance (quantex ASO-CRP-RF control)	Predicate Device Performance
ASO	Statistically similar within-run %CV to quantex ASO plus control	2.8%	1.9% (quantex ASO plus)
CRP	Statistically similar within-run %CV to quantex CRP plus control	3.3%	2.6% (quantex CRP plus)
RF	Statistically similar within-run %CV to quantex RF plus control	1.8%	1.7% (quantex RF plus)
Note: The acceptance criteria are implicitly defined by the performance of the predicate devices. The study aimed to show "statistically similar" performance.

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

Sample Size: The document does not explicitly state the specific number of runs or observations (sample size) used for the comparative performance study on the COBAS Mira. It only reports the calculated %CV values.
Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective performance study conducted by Biokit, comparing their new combined control to existing individual controls.

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

This information is not applicable to this submission. The device is a quality control material for in vitro diagnostics. The "ground truth" for its performance is determined by its analytical characteristics (e.g., precision, accuracy) when measured on an instrument, not by expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not for the analytical performance evaluation of a quality control material.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation (e.g., imaging devices) and aims to assess the impact of AI on reader performance. The "quantex ASO-CRP-RF control" is an in vitro diagnostic quality control material, not subject to MRMC studies.
Effect Size of Human Reader Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was done. The performance study described (comparative performance study on a COBAS Mira) evaluates the performance of the "quantex ASO-CRP-RF control" itself, as a quality control material, without human interpretation in the workflow of the control's function. The control is used to monitor automated instrumentation.

7. Type of Ground Truth Used

The "ground truth" used for this study is the analytical performance characteristics (specifically, within-run variance expressed as %CV) of the predicate devices. The study aimed to demonstrate that the new device's analytical performance was "statistically similar" to these established predicate devices. The "known assayed value" of the analytes (ASO, CRP, RF) within the control material itself acts as an internal reference for the instrument's measurement.

8. Sample Size for the Training Set

This information is not applicable. The "quantex ASO-CRP-RF control" is a ready-to-use quality control material, not an AI or algorithmic device that requires a training set in the typical machine learning sense. Its composition and manufacturing process define its characteristics.

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

This information is not applicable. As stated above, this device is not an AI/ML algorithm requiring a training set with established ground truth labels.

Summary

{0}------------------------------------------------

K971777

MAY 27 1997

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

Submitted by:

国家发布时

Betty Lane Director, Regulatory Affairs Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 phone (617) 861-4182 fax (617) 861-4464

Contact Person:

Betty Lane phone (617) 861-4182

Summary Prepared:

May 2, 1997

Name of the device:

quantex ASO-CRP-RF control

Classification name(s):

Quality Control Material (Assayed and Unassayed) Class I 862.1660

Identification of predicate devices:

quantex ASO plus control	K894486
quantex CRP plus control	K896272
quantex RF plus control	K896271

Description of the device/intended use(s):

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

Biokit's quantex ASO-CRP-RF control substantially equivalent in performance, intended use, safety and effectiveness to the predicate devices: Biokit's quantex ASO plus control (K894486), quantex CRP plus control (K896272), and quantex RF plus control (K896271).

Summary of Performance Data:

In a comparative performance study on a COBAS Mira, the quantex ASO-CRP-RF control exhibited statistically similar with-in run variance to the predicate controls: quantex ASO plus, quantex CRP plus, and quantex RF plus controls. With-in run %CV for the new combined control was 2.8% (ASO), 3.3% (CRP) and 1.8 (RF) as compared to 1.9% (quantex ASO plus), 2.6% (quantex CRP plus) and 1.7% (quantex RF plus).

Section 3

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. 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 symbol that resembles a person with outstretched arms.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 27 1997

Betty Lane Director, Requlatory Affairs Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, Massachusetts 02173-3190

K971777 Re : Biokit's Quantex ASO-CRP-RF Control Regulatory Class: I Product Code: JJT Dated: May 13, 1997 Received: May 14, 1997

Dear Ms. Lane:

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, 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

{2}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity To determine if it does, you should contact categorization. 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 requlation (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 qeneral 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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

{3}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: quantex ASO-CRP-RF control

Indications for Use:

Biokit's ASO-CRP-RF control 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division
Division of Clinical Devices
510(k) Number	K971777

Prescription Use __________ OR __________ Over-The-Counter Use

(Per 21 CFR 801.019)

Section 2 quantex ASO-CRP-RF control 510(k) Page 1 of 1

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.