IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunoassay test procedures that analyze immunochemistries and theraputic drugs as listed in this package insert.

Device Description

IMMUNOASSAY PLUS CONTROL is designed to monitor the performance of test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called "IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3". This is a quality control material used to monitor the performance of immunoassay and therapeutic drug test procedures.

This document describes a substantial equivalence determination for a quality control material, not an AI/ML powered device. Therefore, many of the requested categories (such as human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, and training/test set details typically associated with AI/ML device studies) are not applicable or described in this type of submission.

The study described here is focused on demonstrating that the new control material (IMMUNOASSAY PLUS CONTROL) is substantially equivalent to a previously cleared predicate device (QUALITROL IMMUNOASSAY PLUS CONTROL) based on its intended use and physical properties.

Here's an attempt to fill in the table and answer the questions based on the provided text, noting where information is not applicable or not provided for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this quality control material, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate device. The performance is assessed by comparing key characteristics.

Device Characteristic	Predicate Device (QUALITROL IMMUNOASSAY PLUS CONTROL)	Subject Device (IMMUNOASSAY PLUS CONTROL)	Acceptance Criteria (Implicit for Substantial Equivalence)
Intended Use	Assayed quality control serum for monitoring performance of serum immunoassay and therapeutic drug test procedures.	Assayed quality control serum for monitoring performance of serum immunoassay and therapeutic drug test procedures.	Match the intended use of the predicate device.
Matrix	Human Serum	Human Serum	Match the matrix of the predicate device.
Form	Lyophilized	Lyophilized	Match the form of the predicate device.
Vial	5 mL glass	5 mL glass	Match the vial type of the predicate device.
Analytes	68 analytes of clinical significance	59 analytes of clinical significance	The number of analytes is different but considered acceptable for substantial equivalence, likely because the type of analytes and overall purpose remain the same. The focus is on the device's ability to act as a control for listed analytes, not the sheer number.
Storage	2-8°C	2-8°C	Match the storage conditions of the predicate device.
Stability	Until expiration date noted on vial label.	Until expiration date noted on vial label.	Match the stability claim/method of the predicate device.

Detailed Study Information (Based on availability in the text):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated as a "test set" in the context of an algorithm's performance. For a quality control material, performance is demonstrated by characterizing the material itself against predicate characteristics and potentially through internal validation testing (stability, homogeneity, assigned values), but specific "sample sizes" for a clinical test set are not typically relevant or provided in this type of submission for a control.
Data Provenance: Not specified. As a control material, the performance data would typically be generated by the manufacturer during product development and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. For a quality control material, "ground truth" relates to the assigned values for the analytes within the control. These are established through rigorous testing and assay calibration, not expert consensus in the way an AI diagnostic device would. No experts are mentioned as establishing "ground truth" in the provided text.

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

Not Applicable. Adjudication methods are relevant for ambiguous cases in diagnostic image interpretation or similar tasks; they do not apply to the characterization of a quality control material.

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

No. This type of study (MRMC for human readers with/without AI assistance) is not applicable to a quality control material.

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

Not Applicable. This is not an algorithmic device. Performance is inherent to the control material's composition and manufacturing.

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

For quality control materials, the "ground truth" for the analytes within the control is established by assaying the material against highly calibrated reference methods or against established methods using qualified instruments and reagents. This generally involves internal lab testing and statistical methods to assign target values and ranges, rather than clinical outcomes, pathology, or expert consensus on a diagnostic finding.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device.

Summary

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Product Performance and Substantial Equivalency

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.

The assigned 510(k) number is: 1000237

MAR 1 9 2002

January 21, 2002

Consolidated Technologies Submitter: 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78744 Phone: (512) 445-5100 (512) 445-5515 Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax: Fax:
Contact: Preparation date: Candice Betz

Product name (trade & common):

Proprietary:	IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3
Common:	Ligand Plus, Level 1,2, and 3

MAS Immunoassay (IAC) Control, Levels 1,2, and 3 Also sold as: ICN Immunology 1,2

Classification name:

Class I Product code: JJY

21 CFR 862:1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

Predicate device:

QUALITROL IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3 (510K 992939)

Device description:

The product contains 0.1% sodium azide.

IMMUNOASSAY PLUS CONTROL will be offered in three levels of 5.0 mL filled vials.

Intended use:

IMMUNOASSAY PLUS CONTROL is a lyophilized human serum based assayed quality control material intended to monitor the performance of serum immunoassay test procedures that analyze immunochemistries and therapeutic drugs as listed in the package insert.

Labeling: Immunoassay Plus Control is sold labeled and unlabeled.

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Product Performance and Substantial Equivalency

510(k) Summary (continued)

Comparative analysis:

The table below provides a summary of the technological characteristics between IMMUNOASSAY PLUS CONTROL and the predicate device.

DeviceCharacteristic	IMMUNOASSAY PLUSCONTROL	QUALITROL IMMUNOASSAY PLUSCONTROL
Intended use	Assayed quality control serum formonitoring performance of serumimmunoassay and therapeutic drugtest procedures.	Assayed quality control serum formonitoring performance of serumimmunoassay and therapeutic druqtest procedures.
Matrix	Human Serum	Human Serum
Form	Lyophilized	Lyophilized
Vial	5 mL glass	5 mL glass
Analytes	59 analytes of clinical significancethat may be found in serum.	68 analytes of clinical significancethat may be found in serum.
Storage	2-8°C	2-8°C
Stability	Until expiration date noted on viallabel.	Until expiration date noted on viallabel.

Conclusions:

Conclusions.
The information provided in the pre-market notification demonstrates that MMUNASSAY PLUS The Information provided in the pro manoe readinate device, for which there is FDA carance. This equivalence was demonstrated through comparison of intended uses and physical properties to a equivalence was demonotiation supplied in the pre-market notification provides commercially available device. The information bupplied in safe and effective for the stated intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 9 2002

Ms. Candice Betz Quality Manager Consolidated Technologies 4401 Freidrich Lane Building 1, Suite 100 Austin, TX 78477-1832

Re: K020237

Trade/Device Name: Immunoassay Plus Control, Levels 1, 2, and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I reserved Product Code: JJY Dated: February 18, 2002 Received: March 13, 2002

Dear Ms. Betz:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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

510K Number: K020237

Device name:

IMMUNOASSAY PLUS CONTROL, Levels 1, 2 and 3

Indications for use:

↓ Prescription use

Kim An

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number .. 6020237

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.