Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.

Device Description

Liquichek ToRCH Plus IgM Control, Positive is prepared from negative human serum based material with mouse IgM monoclonal antibodies conjugated to non-specific human IgM molecules for each analyte tested. The positive control reagent also contains constituents of animal origin and preservatives.

AI/ML Overview

Here's an analysis of the provided text regarding the Liquichek ToRCH Plus IgM Control device, focusing on acceptance criteria and supporting studies:

This document ([K040827](https://510k.innolitics.com/search/K040827)) is a 510(k) premarket notification for a Class I medical device, the Liquichek ToRCH Plus IgM Control. As such, the focus of the submission is on demonstrating "substantial equivalence" to a predicate device, rather than proving novel clinical effectiveness through extensive clinical trials with detailed acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity).

The "acceptance criteria" for this type of device are primarily related to its performance as a quality control material (stability, matrix, form, usability) compared to the predicate device, and demonstrating that it meets its intended use of "monitoring precision of IgM laboratory testing procedures." The study provided is a stability study.

Here's the breakdown based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this Class I quality control device are not typically defined by diagnostic performance metrics like accuracy, sensitivity, or specificity in the same way a diagnostic test would be. Instead, they relate to its function as a stable and reliable control material. The "reported device performance" is essentially the results of the stability studies, which demonstrate it meets its intended function over time.

Acceptance Criteria Category	Specific Criterion (Implied/Stated)	Reported Device Performance
Intended Use	Monitor precision of IgM laboratory testing procedures (unassayed).	Confirmed by substantial equivalence to predicate with similar intended use.
Form	Liquid	Is Liquid
Matrix	Human serum based	Is Human serum based
Preservatives	Contains preservatives	Contains preservatives
Open Vial Stability (Storage: 2-8°C)	All analytes stable for 60 days.	All analytes are stable for 60 daysat 2-8°C.
Shelf Life (Storage: -20°C or colder)	All analytes stable for 3 years.	All analytes are stable for 3 years at -20°C or colder.
Number of Levels	Reactive (positive) and Non-reactive (negative)	Provides Reactive and Non-reactive levels.
Analyte Coverage	IgM antibodies to CMV, EBV (VCA), HSV-1/2, Lyme, Rubella, Toxoplasma.	Covers these specified IgM analytes.

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

Sample Size for Test Set: The document does not explicitly state a "sample size" in terms of cases or patient samples for testing diagnostic performance. For a quality control device, the "test set" would refer to the samples (replicates) used in the stability studies. The document states "All supporting data is retained on file at Bio-Rad Laboratories," but does not provide details on the number of control vials tested, the number of replicates per analyte, or the frequency of testing during the stability studies.
Data Provenance: Not explicitly stated beyond "retained on file at Bio-Rad Laboratories." This implies the studies were conducted by Bio-Rad Laboratories themselves, likely in their own facilities. The nature of the device (a control material) suggests the stability testing would be internal R&D/QC, not involving external patient data. It is prospective in the sense that the stability studies were performed to establish the claims.

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

Not applicable for this type of device. The "ground truth" for a quality control material is its known concentration/reactivity, which is internally prepared and characterized by the manufacturer (Bio-Rad Laboratories). Expert consensus regarding diagnostic interpretation of patient cases is not relevant here.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or determine ground truth in situations where variability in interpretation exists (e.g., reading medical images). For a quality control material undergoing stability testing, the "ground truth" is established by the assay methods used during manufacturing and stability monitoring, not by human interpretation requiring adjudication.

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, not a diagnostic AI or imaging device, so MRMC studies, AI effectiveness, or human reader improvement are not relevant.

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

Not applicable. This device is a biochemical quality control material, not an algorithm or AI.

7. The Type of Ground Truth Used

For the purpose of stability testing, the "ground truth" is the initial characterization and measured values of the control material using standardized laboratory assays for each analyte (CMV IgM, EBV IgM, etc.) at the time of manufacturing. The stability studies then monitor how these measured values change over time under specified storage conditions relative to these initial known values or established reference ranges.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not an algorithm or machine learning model that requires a "training set."

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

Not applicable, as there is no "training set" for this device.

Summary

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K040827-

Page 1 of 2

Summary of Safety and Effectiveness MAY 1 9 2004 Liquichek ToRCH Plus IgM Control

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road. Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557

Contact Person

Maria Zeballos Requlatory Affairs Specialist Telephone: (949) 598-1367

Date of Summary Preparation

March 26, 2004

2.0 Device Identification

Product Trade Name:	Liquichek ToRCH Plus IgM Control
Common Name:	Multi-analyte Controls, (Assayed and unassayed)
Classifications:	Class I
Product Code:	JJY
Regulation Number:	CFR 862.1660

3.0 Device to Which Substantial Equivalence is Claimed

VIROCLEAR ToRCH & VIROCLEAR ToRCH -M Blackhawk BioSystems, Inc. San Ramon, California

510 (k) Number: K942295

4.0 Description of Device

Analyte Cytomegalovirus (CMV) Epstein-Barr Virus EBV (VCA) gp125 Herpes Simplex Virus Type 1 (HSV-1) gC1 Herpes Simplex Virus Type 2 (HSV-2) gG2 Lyme (Borrelia burgdorferi) Rubella Virus E1 Toxoplasma gondii p30

IgM Monoclonal antibody specificity p52, pp65, and gB OspA and OspB

08_510(k) Torch IgM_ 229_ 04/04

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5.0 Intended Use

Comparison of the new device with the Predicate Device 6.0

Liguichek ToRCH Plus IgM Controls claim substantial equivalency to the VIROCLEAR ToRCH and VIROCLEAR ToRCH-M Controls currently in commercial distribution (K942295).

	Bio-Rad	Blackhawk BioSystems, Inc.
Characteristics	Liquichek™ ToRCH Plus IgM Control(New Device)	VIROCLEAR ToRCH Control(Predicate Device K942295)
Similarities
Intended Use	Liquichek ToRCH Plus IgM Control is intended for use as anunassayed quality control serum to monitor precision of IgMlaboratory testing procedures for the analytes listed in thispackage insert. This product is not intended for use in blooddonor screening assays.	VIROCLEAR ToRCH / VIROCLEAR ToRCH-M: is intendedfor use as an unassayed precision quality reagent with invitro assay procedure for determination of IgG and IgMantibodies to TOXO, Rubella virus CMV and HSV (1 & 2)
Form	Liquid	Liquid
Matrix	Human serum based	Human serum based
Preservatives	Contains preservatives	Contains preservatives
Open Vial Claim	60 days at 2 to 8°C	60 days at 2°C to 8°C
Number of Levels	Reactive (positive) and Non-reactive (negative)	Reactive and Non-reactive
Differences
Storage (Unopened)	-20°C or colderUntil expiration date	2°C – 8°CUntil expiration date
Analytes	IgM antibodies to:Cytomegalovirus (CMV)Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA)Herpes Simplex Virus Type 1/2 (HSV-1/2)Lyme (Borrelia burgdorferi)Rubella VirusToxoplasma gondiiIt does not test for antibodies to IgG	IgM and IgG antibodies to:Cytomegalovirus (CMV)Herpes Simplex Virus Type 1/2 (HSV-1/2)Rubella VirusToxoplasma gondiiIt does not test for antibodies to:- Lyme (Borrelia burgdorferi)- Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA)

Table 1. Similarities and Differences between new and predicate device.

7.0 Statement of Supporting Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ToRCH Plus IgM Control. Product claims are as follows:

7.1 Open vial: All analytes will be stable for 60 days when stored at 2 to 8°C.
7.2 Shelf Life: 3 Years at -20°C or colder
7.3 Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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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 depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 9 2004

Ms. Elizabeth Platt Regulatory Affairs Manager/Quality Assurance Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, CA 92618-2017

K040822 Re:

Trade/Device Name: Liquichek™ ToRCH Plus IgM Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: March 26, 2004 Received: March 30, 2004

Dear Ms. Platt:

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 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 mcan 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). You may obtain other general information on your responsibilities under the Act 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,

Saqarts

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K040822
Device Name:	Liquichek ToRCH Plus IgM Control
Indications For Use:	Liquichek ToRCH Plus IgM Control is intended for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for the analytes listed in this package insert. This product is not intended for use in blood donor screening assays.

Analytes Listed in the package insert:

Cytomegalovirus (CMV) IgM
Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA) IgM
Herpes Simplex Virus Type 1/2 (HSV-1/2) IgM
Lyme (Borrelia burgdorferi) IgM
Rubella Virus IgM
Toxoplasma gondii IgM

Prescription Use_ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Vagaxh
Division Sign-Off

Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Saffety

510(k) _ KO40827

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.