Qualitrol Immunology Control, Level 1, 2 and 3, is a lyophilized human serum based assayed quality control material intended to monitor the performance of clinical immunological test procedures that analyze immunoglobulins and other serum proteins.

Device Description

Qualitrol Immunology Control, is designed to monitor the performance of test procedures that analyze immunoqlobulin and other proteins in serum. Human origin components are added to a human serum based matrix. The product contains 0.1% sodium azide. Qualitrol Immunology Control will be offered in three levels of 5.0 mL fill vials.

AI/ML Overview

This submission describes a quality control material rather than a diagnostic device, therefore, the typical acceptance criteria and study designs are not directly applicable in the same way they would be for an AI-powered diagnostic tool. The "performance" being evaluated is its suitability as a control material, primarily by comparing its characteristics to a legally marketed predicate device.

Here's how the provided information relates to your request, with explanations for where certain criteria are not applicable:

1. Table of Acceptance Criteria and the Reported Device Performance

For this type of device, the "acceptance criteria" are implied by the characteristics of the predicate device and the manufacturer's claim of "substantial equivalence." The reported "device performance" is a comparison of these characteristics.

Device Characteristic	Qualitrol Immunology Control (Reported Performance)	Acceptance Criteria (Implied by Predicate Device: Liquichek™ Immunology Plus Control)
Intended Use	Assayed quality control serum for monitoring performance of serum immunological test procedures.	Assayed quality control serum for monitoring precision of laboratory testing procedures.
Matrix	Human Serum	Human Serum
Form	Lyophilized	Liquid
Analytes	26 analytes of clinical significance that may be found in serum.	24 analytes
Storage	2-8°C	2-8°C
Stability	Until expiration date noted on vial label.	Until expiration date noted on vial label.

Explanation of "Acceptance": The FDA's letter (K992770) explicitly states: "We have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "acceptance" for marketing the product. The minor differences (e.g., number of analytes, lyophilized vs. liquid form) were deemed not to raise new questions of safety or effectiveness.

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

Sample Size: Not applicable in the traditional sense of a diagnostic test set. This is a quality control material, and the "test" involved comparing its formulation and intended use characteristics against a predicate device. Performance would typically be assessed during internal validation of its stability, analyte levels, and consistency, but those details are not provided in this 510(k) summary.
Data Provenance: Not explicitly stated. The comparison is against a commercially available predicate device (LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651). The information provided is a comparative analysis of product characteristics.

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

Not applicable. "Ground truth" in the context of a quality control material refers to the established target values for the analytes within the control. This is typically determined through rigorous analytical methods and inter-laboratory studies conducted by the manufacturer, rather than by human experts establishing diagnostic "ground truth" as in an imaging study. The provided document focuses on the equivalence of the control's characteristics to another control, not its accuracy in mimicking a clinical condition.

4. Adjudication method for the test set

Not applicable. There was no "test set" requiring adjudication in the diagnostic sense. The comparison was a direct assessment of physical and functional characteristics against a predicate device.

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 an immunology control, not an AI-assisted diagnostic tool. Therefore, no MRMC study, human reader improvement, or AI component is relevant.

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

Not applicable. This device is an immunology control, not an algorithm.

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

For this device, "ground truth" (if we stretch the definition) would refer to the assigned values of the analytes within the control material, and the physical/chemical properties that define it as a suitable control. These are established through manufacturing processes, analytical testing, and stability studies, not expert consensus, pathology, or outcomes data related to patient diagnosis. The document primarily uses the characteristics of the predicate device as a benchmark.

8. The sample size for the training set

Not applicable. This is a quality control material, not a machine learning model. There is no concept of a "training set" for its development or validation as described in this document.

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

Not applicable. As above, there is no training set for this product.

Summary

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NOV 1 2 1999

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: _ _ 992720

SeraCare Technology, Inc. DBA Consolidated Technologies Submitter: 2170 Woodward Street Austin, TX 78744-1832 Phone: (512) 445-5100 Fax: (512) 445-5515

Preparation date: August 13, 1999 Contact: Rusty Sewell

Product name (trade & common):

Proprietary: Qualitrol Immunology Control, Levels 1, 2 and 3 Common: Not Applicable

Classification name:

Class 1 . Product code: JJY 21 CFR 862:1660 : Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

Predicate device:

LIQUICHEK IMMUNOLOGY CONTROL, BIO-RAD Laboratories K-945651

Device description:

Intended use:

Qualitrol Immunology Control is a Iyophilized human serum based assayed quality control material intended to monitor the performance of serum immunological test procedures that analyze immunoglobulins and other serum proteins.

Labeling: Vial labels see Attachments I Secondary Container label, see Attachments II Package Insert, see Attachment III

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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 Qualitrol Immunology Control and the predicate device.

DeviceCharacteristic	Qualitrol ImmunologyControl	Liquichek™ Immunology PlusControl
Intended use	Assayed quality control serum formonitoring performance of serumimmunological test procedures.	Assayed quality control serum formonitoring precision of laboratorytesting procedures.
Matrix	Human Serum	Human Serum
Form	Lyophilized	Liquid
Analytes	26 analytes of clinical significancethat may be found in serum.	24 analytes
Storage	2-8°C	2-8°C
Stability	Until expiration date noted on viallabel.	Until expiration date noted on viallabel

Conclusions:

The information provided in the pre-market notification demonstrates that Qualitrol Immunology Control is substantially equivalent to the predicate device, for which there is FDA clearance. This equivalence was demonstrated through comparison of intended uses and physical properties to a commercially available device. The information supplied in the pre-market notification provides reasonable assurance that Qualitrol Immunology Control is safe and effective for the stated intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines representing hair or fabric.

NOV 1 2 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA, Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832

K992770 Re:

Trade Name: Qualitrol Immunology Control, Level 1, 2 and 3 Regulatory Class: I Product Code: JJY Dated: August 13, 1999 Received: August 17, 1999

Dear Mr. Sewell:

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 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 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 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.

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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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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510(k) Number (if known): $993720

Device Name:__________________________________________________________________________________________________________________________________________________________________

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Indications For Use:

Qualitrol Immunology Control, Level 1, 2 and 3 Device name: Indications for use:

(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)
Division of Clinical Laboratory Devices
510(k) Number	K992770

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Format 1-2-96)

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.