LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL

K043108 · Bio-Rad Laboratories, Inc. · JJY · Dec 7, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043108
• Device Name: LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
• Applicant: Bio-Rad Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 7, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek™ Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert

Device Story

Liquichek™ Specialty Immunoassay Control is a multi-analyte quality control serum used in clinical laboratories to monitor the precision of immunoassay testing procedures. The device consists of human serum supplemented with chemicals, stabilizers, and preservatives (5-chloro-2-methyl-2H-isothiazol-3-1). It is provided in three levels as a ready-to-use liquid. Laboratory personnel use the control to verify the performance of assays for Anti-TG, Anti-TPO, C-peptide, EPO, iPTH, IGF-1, Osteocalcin, and 25-OH Vitamin D. By comparing observed results against assigned mean values and ranges provided in the package insert, clinicians can assess the stability and accuracy of their testing systems. The device serves as an external quality control measure to ensure reliable diagnostic results for patients.

Clinical Evidence

No clinical data. Bench testing only. Stability studies were conducted to validate open vial stability (30 days at 2-8°C, with 21-day exceptions for Anti-Tg and Anti-TPO) and shelf-life stability (2 years at -20°C to -70°C) using accelerated and real-time testing protocols.

Technological Characteristics

Matrix: Human serum with added human/animal constituents, chemicals, stabilizers, and preservatives. Form: Liquid. Storage: -20 to -70°C. Analyte list: Anti-Tg, Anti-TPO, C-peptide, EPO, iPTH, IGF-I, Osteocalcin, 25-OH Vitamin D.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific analytes (Anti-Tg, Anti-TPO, C-peptide, EPO, iPTH, IGF-I, Osteocalcin, 25-OH Vitamin D) in clinical laboratory settings.

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

• Lypochek Immunoassay Plus Control (k981532)

Submission Summary (Full Text)

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

## Summary of Safety and Effectiveness Liquichek Spacialty Immunoassay Control

#### 1.0 Submitter

DEC - 7 2004

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: [phone] [phone] Fax:

## Contact Person

Suzanne Parsons Regulatory Affairs Specialist Telephone: [phone]

## Date of Summary Preparation

November 2, 2004

#### 2.0 Device Identification

| Product Trade Name: | Liquichek Specialty Immunoassay Control |
|---------------------|-------------------------------------------------|
| Common Name: | Multi-analyte controls, (assayed and unassayed) |
| Classifications: | Class I |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |

#### 3.0 Device to Which Substantial Equivalence is Claimed

Lyphochek Immunoassay Plus Control Bio-Rad Laboratories Irvine, California

510 (k) Number: K981532

#### 4.0 Description of Device

Liquichek Specialty Immunoassay Control is prepared from human serum with added constituents of human and animal origin, chemicals, stabilizers, and preservatives. This provided in liquid form.

#### 5.0 Intended Use

Liquichek Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for analyte listed in the package insert.

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

#### 6.0 Comparison of the new device with the Predicate Device

Liquichek Specialty Immunoassay Control claims substantial equivalence to the Lyphochek Immunoassay Plus Control currently in commercial distribution (K981532). Both products are serum based products that contain muliple analytes used to monitor precision of laboratory testing procedures.

| Characteristics | Bio-Rad Laboratories<br>Bio-Rad Liquichek Specialty Immunoassay Control<br>(New Device) | Bio-Rad Laboratories<br>Lyphochek Immunoassay PlusControl<br>(Predicate Device K981532) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Liquichek Specialty Immunoassay Control is intended for use as<br>quality control serum to monitor the precision of laboratory testing<br>procedures listed in the package insert. | Lyphochek Immunoassay Plus Control is intended for use as<br>quality control serum to monitor the precision of laboratory testing<br>procedures listed in the package insert |
| Stabilizers | Contains Stabilizers | Contains Stabilizers |
| Matrix | Human Serum | Human Serum |
| Differences | | |
| Form | Liquid | Lyophilized |
| Preservatives | Contains Preservatives | None |
| Storage<br>(Unopened) | -20 to -70°C<br>Until expiration date | 2 to 8°C<br>Until expiration date |
| Open Vial | 30 days at 2-8°C with the following exceptions: Anti-Tg and Anti-<br>TPO will be stable for 21 days | 7 days at 2 to 8 °C with the following exceptions: (1) Folate and<br>PSA will be stable for 3 days after reconstitution, (2) C-Peptide<br>will be stable for 1 day, (3) Intact PTH will be stable for 16 hours<br>after reconstitution, and (4) ACTH, Calcitonin, Gastrin and Free<br>PSA should be assayed immediately after reconstitution. |
| Alternate storage | None | After reconstituting and freezing: all analytes will be stable for 20<br>at -10 to -20°C with the following exceptions: no frozen stability<br>claim is supplied for ACTH, Aldosterone, Androstenedione,<br>Calcitonin and C-Peptide. |
| Analytes | Contains only the following analytes:<br>• Anti-Tg<br>• Anti-TPO<br>• C-peptide<br>• Erythropoietin (EPO)<br>• Intact PTH (iPTH)<br>• IGF-I<br>• Osteocalcin<br>• 25-OH Vitamin D | Contains the following analytes:<br>Multi anlyte including:<br>• 25-OH Vitamin D<br>• C-peptide<br>• Intact PTH (iPTH)<br>Does not contain:<br>• Anti-Tg<br>• Anti-TPO<br>• Erythropoietin (EPO)<br>• IGF-I<br>• Osteocalcin |

### 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 Specialty Immunoassay Control. Product claims are as follows:

| 7.1 | Open vial | 30 days at 2°C to 8°C with the following exceptions: Anti-<br>Tg and Anti-TPO will be stable for 21 days |
|-----|----------------------|----------------------------------------------------------------------------------------------------------|
| 7.2 | Shelf Life Stability | 2 Years at -20 to -70°C |

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC - 7 2004

Ms. Suzanne S. Parsons Regulatory Affairs Specialist Bio-Rad Laboratories. Inc. 9500 Jeronimo Rd. Irvine, CA 92618-2017

Re: k043108

Trade/Device Name: Liquichek Specialty Immunoassay Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: November 4, 2004 Received: November 9, 2004

Dear Ms Parsons:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 legally

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

Page 2 – Ms. Suzanne S. Parsons

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), please contact the Office of Compliance 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,

Lala M. Beattie/

Robert L. Becker, Jr., M.B., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

| 510(k) Number (if known): | K043108 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Liquichek Specialty Immunoassay Control |
| Indications For Use: | Liquichek Specialty Immunoassay Control is intended for use as a<br>quality control serum to monitor the precision of laboratory testing<br>procedures listed in the package insert. |

× Prescription Use_ (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)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Mana Clan

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K043108