Liquichek Maternal Serum II Control

K143379 · Bio-Rad Laboratories · JJY · Mar 13, 2015 · Clinical Chemistry

Device Facts

• Record ID: K143379
• Device Name: Liquichek Maternal Serum II Control
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Maternal Serum II Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Analytes are: AFP, hCG, unconjugated Estriol, and Inhibin A. For Prescription use only.

Device Story

Liquichek Maternal Serum II Control is an assayed quality control serum used in clinical laboratories to monitor the precision of testing procedures for specific analytes (AFP, hCG, Unconjugated Estriol, Inhibin A). The device is prepared from defibrinated human plasma with added constituents, stabilizers, and preservatives. It is provided in a liquid form, contrasting with the lyophilized predicate. The control is used by laboratory personnel to verify the performance of analytical instruments and reagents. By comparing observed results against the provided mean values and ranges, clinicians can assess the reliability of patient test results. The product is stored frozen (-20 to -70°C) and has established stability for thawed (opened and unopened) use at 2 to 8°C. It benefits patients by ensuring the accuracy and consistency of maternal serum screening tests.

Clinical Evidence

No clinical data. The device is a quality control material; performance was established through bench testing, including real-time and accelerated stability studies to determine shelf life and thawed stability.

Technological Characteristics

Quality control material derived from defibrinated human plasma. Contains added chemical constituents, stabilizers, and preservatives. Liquid form. Analytes: AFP, hCG, Unconjugated Estriol, Inhibin A. Storage: -20 to -70°C. Stability: 40 days thawed/unopened, 30 days thawed/opened. Non-reactive for HBsAg, HCV, and HIV-1/HIV-2.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for AFP, hCG, Unconjugated Estriol, and Inhibin A. For 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

• Lyphochek Maternal Serum Control (K984594)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2015

BIO-RAD LABORATORIES SUZANNE PARSONS REGULATORY AFFAIRS MANAGER 9500 JERONIMO ROAD IRVINE CA 92618

Re: K143379

Trade/Device Name: Liquichek Maternal Serum II Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (assayed and unassayed) Regulatory Class: Class I, Reserved Product Code: JJY Dated: February 9, 2015 Received: February 11, 2015

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Katherine Serrano -A

For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) k143379

Device Name Liquichek Maternal Serum II Control

## Indications for Use (Describe)

Liquichek Maternal Serum II Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

> Analytes are: AFP hCG Unconjugated Estriol Inhibin A

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" width="15" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" stroke-width="2" x1="13" x2="2" y1="2" y2="13"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: sans-serif;"> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" width="15" x="0" y="0"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

|_ | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

## Liquichek Maternal Serum II Control

#### 1.0 Submitter

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

## Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: [phone]

## Date of Summary Preparation

March 12, 2015

#### 2.0 Device Identification

Product Trade Name: Common Name: Classifications: Product Code: Regulation Number:

Liquichek Maternal Serum II Control Multi-Analyte Controls, All Kinds (Assayed) Class I, Reserved JJY 21 CFR 862.1660

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

Lyphochek Maternal Serum Control Bio-Rad Laboratories Predicate 510(k) Number: K984594

#### 4.0 Description of Device

Liquichek Maternal Serum II Control is prepared from defibrinated human plasma with added constituents of human origin, chemicals, stabilizers, and preservatives. The control is provided in liquid form for convenience.

## Table 1: Product Catalog Description

| Level | Configuration |
|------------------------------------------------------|----------------------------------|
| Liquichek Maternal Serum II Control Level 1 | 6 x 2.5 mL |
| Liquichek Maternal Serum II Control Level 2 | 6 x 2.5 mL |
| Liquichek Maternal Serum II Control Level 3 | 6 x 2.5 mL |
| Liquichek Maternal Serum II Control Trilevel MiniPak | 3 x 2.5 mL<br>(1 vial per level) |

Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.

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#### 5.0 Intended Use

T

Liquichek Maternal Serum II Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

#### 6.0 Comparison of the New Device with the Predicate Device

Liquichek Maternal Serum II Control claims substantial equivalence to Lyphochek Maternal Serum Control (K984594). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

Liquichek Maternal Serum II Lyphochek Maternal Serum Characteristics Control Control (New Device) (Predicate Device, K984594) Similarities Liquichek Maternal Serum II Same Intended Use Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Base Matrix Defibrinated Human Plasma Same Differences Form Liquid Lyophilized Fill Size 2.5 mL 5 mL Thawed and 40 days at 2 to 8°C No claims made Unopened Stability Thawed and Opened Vial 30 days at 2 to 8°C 10 days at 2 to 8°C / After Reconstitution Shelf Storage & -20 to -70°C until the expiration 2 to 8°C until the expiration date Stability (Unopened) date Analytes Contains: Contains: AFP AFP hCG hCG Estriol, Free Estriol, Free Inhibin A Does not contain: Inhibin A

a Table 2: Similarities and Differences Between the New Device and the Predicate Device

#### 7.0 Traceability:

The analytes contained in the Liquichek Maternal Serum II Control are obtained from commercially available sources, except for Inhibin A which is internally sourced.

#### 8.0 Value Assignment

The mean values and corresponding ±3SD ranges printed in the insert were derived from replicate analyses and are specific for the lot of the product. The tests listed were performed by the manufacturer and/or independent laboratories using manufacturer supported reagents and a representative sampling of this lot of product. It is recommended that each laboratory establish its own acceptable ranges and use those provided only as guides. Laboratory established ranges may vary from those listed during

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the life of this control. Variations over time and between laboratories may be caused by differences in laboratory technique, instrumentation and reagents, or by manufacturer test method modifications.

#### 9.0 Stability:

Real time stability studies were performed to establish thawed (opened and unopened vial) stability claims. Accelerated stability studies were performed to establish the shelf life stability claims with real-time stability ongoing. The stabilities for Liquichek Maternal Serum II Control are as follows:

| Thawed and Unopened Stability | 40 days at 2 to 8°C |
|-------------------------------|---------------------------|
| Thawed and opened Stability | 30 days at 2 to 8°C |
| Shelf Life Stability: | 40 months at -20 to -70°C |

#### 10.0 Conclusion

Based on the performance characteristics indicated above, Liquichek Maternal Serum II Control is substantially equivalent to the predicate device (K984594).

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