LIQUICHEK TORCH PLUS IGM CONTROL

K040822 · Bio-Rad Laboratories, Inc. · JJY · May 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040822
• Device Name: LIQUICHEK TORCH PLUS IGM CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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

Device Story

Liquichek™ ToRCH Plus IgM Control serves as unassayed quality control material for laboratory IgM testing. Kit includes positive and negative controls; processed identically to patient specimens. Matrix consists of negative human sera spiked with mouse IgM monoclonal antibodies conjugated to human IgM. Used in clinical laboratories to monitor precision of IgM assays for Toxoplasma gondii, Rubella, CMV, HSV-1/2, EBV VCA, and Lyme disease. Does not provide diagnostic results; assists in verifying assay performance stability.

Clinical Evidence

No clinical data. Evidence consists of bench testing, specifically stability studies confirming 60-day open-vial stability at 2-8°C and 3-year shelf life at -20°C or colder.

Technological Characteristics

Liquid, serum-based control material. Contains negative human sera and mouse IgM monoclonal antibodies conjugated to human IgM. Unassayed. Designed for use with analyte-specific EIA testing procedures.

Indications for Use

Indicated for use as an unassayed quality control serum to monitor precision of IgM laboratory testing procedures for Toxoplasma gondii, Rubella, CMV, HSV-1/2, EBV VCA, and Lyme (Borrelia burgdorferi) IgM. Not for blood donor screening. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• VIROTROL ToRCH (k942295)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

### Contact Person

Maria Zeballos Requlatory Affairs Specialist Telephone: [phone]

### 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

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. The following are the specificities of each monoclonal antibody:

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

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.

#### 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<br>(New Device) | VIROCLEAR ToRCH Control<br>(Predicate Device K942295) |
| Similarities | | |
| Intended Use | Liquichek ToRCH Plus IgM Control is intended for use as an<br>unassayed quality control serum to monitor precision of IgM<br>laboratory testing procedures for the analytes listed in this<br>package insert. This product is not intended for use in blood<br>donor screening assays. | VIROCLEAR ToRCH / VIROCLEAR ToRCH-M: is intended<br>for use as an unassayed precision quality reagent with in<br>vitro assay procedure for determination of IgG and IgM<br>antibodies 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 colder<br>Until expiration date | 2°C – 8°C<br>Until expiration date |
| Analytes | IgM antibodies to:<br>Cytomegalovirus (CMV)<br>Epstein-Barr Virus (EBV) Viral Capsid Antigen (VCA)<br>Herpes Simplex Virus Type 1/2 (HSV-1/2)<br>Lyme (Borrelia burgdorferi)<br>Rubella Virus<br>Toxoplasma gondii<br>It does not test for antibodies to IgG | IgM and IgG antibodies to:<br>Cytomegalovirus (CMV)<br>Herpes Simplex Virus Type 1/2 (HSV-1/2)<br>Rubella Virus<br>Toxoplasma gondii<br>It does not test for antibodies to:<br>- Lyme (Borrelia burgdorferi)<br>- 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 [phone]. 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 [phone] or [phone] 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