K Number

Device Name

LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK

Manufacturer

Bio-Rad Laboratories

Date Cleared

2014-04-25

(29 days)

Product Code

JJY REG

Regulation Number

862.1660

Intended Use

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

Device Description

Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, stabilizers and preservatives. This provided in liquid form for convenience. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K022991

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a quality control serum for laboratory testing and makes no mention of AI or ML.

Therapeutic

No.
The "Intended Use" states that it is an assayed quality control serum to monitor the precision of laboratory testing procedures, not to treat or diagnose.

Diagnostic

No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures." This indicates it's used for quality control of testing equipment, not for directly diagnosing a patient's condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a liquid control serum prepared from human plasma, indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This is a classic function of an IVD, specifically a quality control material used in laboratory testing.
Device Description: It's a "quality control serum" prepared from human plasma, designed to be used in laboratory settings.
Intended User / Care Setting: It's intended for "laboratory testing procedures," which aligns with the use of IVDs.

The fact that it's a quality control material used in laboratory tests to ensure the accuracy of those tests firmly places it within the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

JJY

Device Description

Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, stabilizers and preservatives. This provided in liquid form for convenience.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Real time stability studies were performed to establish Thawed and Thawed and unopened stability claims. Accelerated stability studies were performed for establishing the shelf life stabilities for Liquichek Immunology Control are as follows

Thawed and Opened Stability: Beta-2-Microglobulin: 21 days at 2 to 8°C Rheumatoid Factor: 10 days at 2 to 8°C All other analytes: 30 days at 2 to 8°C
Thawed and Unopened Stability: Beta-2-Microglobulin: 40 days at 2 to 8°C Rheumatoid Factor: 10 days at 2 to 8°C All other analytes: 45 days at 2 to 8°C
Shelf Life stability: 24 months at -20 to -70°C

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K022991

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

K140764

Page 1 of 3

510(k) Summary

Liquichek Immunology Control

APR 2 5 2014

1.0 Submitter

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

Contact Person

Suzanne Parsons RA/QA Supervisor Telephone: (949) 598-1467

Date of Summary Preparation

March 25th, 2014

2.0 Device Identification

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

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

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Immunology Control Bio-Rad Laboratories Predicate 510(k) Number: K022991

4.0 Description of Device

Liquichek Immunology Control is prepared from defibrinated human plasma with added serum proteins, stabilizers and preservatives. This provided in liquid form for convenience.

5.0 Value Assignment

The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts (available separately) were derived from replicate analyses and are specific for this lot of product. Data from Unity™ Interlaboratory Program are included in the determination of some ranges. 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 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.

6.0 Intended Use

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

7.0 Comparison of the new device with the Predicate Device

Liquichek Immunology Control claims substantial equivalence to Liquichek Immunology Control (K022991). Table 1 (below) contains comparison information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

			Table 2: Comparison between the predicate and new Liquichek Immunology Control
Characteristics	Predicate Device			New Device
	Liquichek Immunology Control (K022991)			Liquichek Immunology Control
			Similarities
Product Name			Liquichek Immunology Control		Liquichek Immunology Control
Intended Use			Liquichek Immunology Control is intended for use as an
assayed quality control serum to monitor the precision
of laboratory testing procedures for the analytes listed
in this package insert.			Liquichek Immunology Control is intended for use as an
assayed quality control serum to monitor the precision of
laboratory testing procedures for the analytes listed in this
package insert.
Base Matrix	Defibrinated Human Plasma			Defibrinated Human Plasma
Form	Liquid			Liquid
Thawed and
Opened Stability	30 days at 2 to 8°C			30 days at 2 to 8°C
	Except		Beta-2-Microglobulin: 21 days at 2 to 8°C
Rheumatoid Factor: 5 days at 2 to 8°C	Except		Beta-2-Microglobulin: 21 days at 2 to 8°C
Rheumatoid Factor: 10 days at 2 to 8°C
Shelf life			-20 to -70°C until expiration		-20 to -70°C until expiration
			Differences
Thawed and
Unopened Stability			All analytes: 90 days at 2 to 8°C		All analytes: 45 days at 2 to 8°C
	Except		Rheumatoid Factor: 25 days at 2 to 8°C	Except	Beta-2-Microglobulin: 40 days at 2 to 8°C
Rheumatoid Factor: 10 days at 2 to 8°C
Analytes	Contains			Contains
	ADNase B		IgG Subclass 1	ADNase B	Hemopexin
	Albumin		IgG Subclass 2	Albumin	IgG Subclass 1
	Alpha 1-Antitrypsin		IgG Subclass 3	Alpha 1-Antitrypsin	IgG Subclass 2
	Alpha 2-Macroglobulin		IgG Subclass 4	Alpha 2-Macroglobulin	IgG Subclass 3
	Alpha-1-Acid Glycoprotein		Immunoglobulin A
Immunoglobulin E	Alpha-1-Acid Glycoprotein
Anti-CCP		IgG Subclass 4
Immunoglobulin A
	Antistreptolysin-O
Antithrombin III (AT III)
Apolipoprotein A-I
Apolipoprotein B
Beta-2-Microglobulin
C1 Inhibitor		Immunoglobulin G	Antistreptolysin-O
Antithrombin III (AT III)		Immunoglobulin E
			Immunoglobulin M		Immunoglobulin G
			Kappa Light Chain	Apolipoprotein A-I	Immunoglobulin M
			Lambda Light Chain	Apolipoprotein B
Beta-2-Microglobulin		Kappa Light Chain
			Lipoprotein (a)		Lambda Light Chain
	Ceruloplasmin		Prealbumin	C1 Inhibitor	Lipoprotein (a)
	Complement C3		Properdin Factor B	Ceruloplasmin	Prealbumin
	Complement C4		Protein Serum (Total)	Complement C3	Properdin Factor B
		C-Reactive Protein (CRP)	Retinol Binding Protein	Complement C4	Protein Serum (Total)
		C-Reactive Protein (hsCRP)	Rheumatoid Factor	C-Reactive Protein (CRP)	Retinol Binding Protein
	Cystatin C		Soluble Transferrin Receptor	C-Reactive Protein (hsCRP)	Rheumatoid Factor
	Ferritin		Total Hemolytic Complement	Cystatin C	Soluble Transferrin Receptor
	Haptoglobin		Transferrin	Ferritin	Total Hemolytic Complement
	Hemopexin			Haptoglobin	Transferrin
	Does not contain:
	Anti-CCP

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

8.0 Statement of Supporting Data

| Thawed and Opened Stability | Beta-2-Microglobulin: 21 days at 2 to 8°C
Rheumatoid Factor: 10 days at 2 to 8°C
All other analytes: 30 days at 2 to 8°C |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Thawed and Unopened Stability | Beta-2-Microglobulin: 40 days at 2 to 8°C
Rheumatoid Factor: 10 days at 2 to 8°C
All other analytes: 45 days at 2 to 8°C |
| Shelf Life stability: | 24 months at -20 to -70°C |

9.0 Conclusion

Based on the performance characteristics indicated above, Liquichek Immunology Control is substantially equivalent to the predicate device (K022991).

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

April 25, 2014

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

Re: K140764

Trade/Device Name: Liquicheck Immunology Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJY Dated: March 25, 2014 Received: March 27, 2014

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 Parts 801 and 809); medical device 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.

Page 2-Ms. Parsons

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Elizabeth A. Stafford -S

for Maria M. Chan, Ph.D.

Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140764

Device Name

Liquichek Immunology Control

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth A. Stafford -S

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