Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a quality control serum for laboratory testing and does not mention any AI or ML components.

Therapeutic

No.
The device is described as a quality control serum to monitor the precision of laboratory testing procedures, not to treat a condition or disease.

Diagnostic

No
The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," not to diagnose diseases or conditions in patients.

SaMD (Software as a Medical Device)

No

The device is a liquid control serum, which is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this 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 the package insert." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this control itself isn't directly diagnosing a patient, it's an essential component in ensuring the accuracy and reliability of the diagnostic tests being performed in the laboratory.
Device Description: It's prepared from human serum and other constituents, and it's used in a laboratory setting.
Intended User / Care Setting: It's used in "laboratory testing procedures," which is the typical environment for IVDs.
Predicate Device: The mention of a predicate device (K001373; Liquichek Immunoassay Plus Control) which is also a quality control material, further supports its classification as an IVD. Quality control materials are considered IVDs because they are used in conjunction with diagnostic tests.

Therefore, the Liquichek Immunoassay Premium Control fits the criteria of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Liquichek Immunoassay Premium 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 immunoassay Premium Control is prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is 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 Hepatitls B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests.

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

laboratory testing procedures

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)

Accelerated Stability studies have been performed to predict the Shelf life stability and real time studies were conducted to establish Thawed (opened and unopened) & Frozen aliquot claims for Liquichek Immunoassay Premium Control. Product claims are as follows:

Thawed Opened Stability: 14 days at 2 to 8°C (for most analytes)
Thawed Unopened Stability: 28 days at 2 to 8°C (for most analytes)
Frozen Aliquot: 28 days at -20°C to -70°C
Shelf Life Stability: 28 Months at -20°C to -70°C (for most analytes)

The acceptance criteria for above studies is defined as the recovery result on final day (TFInal) being ± 10% of the recovery result of time zero vial (Tzero).

Real-time stability studies are ongoing to support the shelf life of this product.

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

Not Found

Predicate Device(s)

K001373

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

0

K 132227

510(k) Summary

Liquichek Immunoassay Premium Control

1.0 Submitter

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

Contact Person

Suzanne Parsons Regulatory Affairs Manager Telephone: (949) 598-1467

OCT 2 5 2013

Date of Summary Preparation

October 17, 2013

2.0 Device Identification

Product Trade Name: Liquichek Immunoassay Premium Control Common Name: Multi-Analyte Controls, All Kinds (Assayed) Classifications: Class I, Reserved Product Code: JJY Regulation Number: 21 CFR 862,1660

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek Immunoassay Plus Control Blo-Rad Laboratories Irvine, California

510 {k} Number: K001373

4.0 Description of Device

Liquichek immunoassay Premium Control is prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is 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 Hepatitls B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product may also contain other human source material for which there are no approved tests.

1

5.0 Value Assignment

The mean values and the corresponding ±3SD ranges printed In this Insert 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 Immunoassay Premium 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 Immunoassay Premium Control claims substantial equivalence to the Liquichek Immunoassay Pius Control currently in commercial distribution (K001373). Table 1 (below) contains comparison Information of similarities and differences between the new and predicate device to which substantial equivalence is claimed.

| Characteristics | Liquichek Immunoassay Promium Control
(New Device) | | Liquichek Immunoassay Plus Control
(Predicate Device, K001373) | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| | Similarities | | | |
| Intended Use | Liquichek Immunoassay Premium 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 Immunoassay Plus 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. | |
| Matrix | Human Serum | | Human Serum | |
| Form | Liquid | | Liquid | |
| Storage unopened
(Shelf life) | -20°C to -70°C until expiration date | | -20°C to -70°C until expiration date | |
| | Differences | | | |
| Fill Volume | Trilevel, Level 1, 2 and 3 – 6 x 5 mL
Trilevel MiniPak - 3 x 5 mL | | Level 1, 2 and 3– 12 x 5 mL
Trilovol MiniPak - 3 x 5 mL | |
| Thawed Opened
Stability | 14 days at 2 to 8°C | | 14 days at 2°C to 8 °C | |
| | Except | Folate: 4 days at 2 to 8°C
Estradiol: 5 days at 2 to 8°C
Free PSA: 7 days at 2 to 8°C
Vitamin D: 9 days at 2 to 8°C
Total PSA: 13 days at 2 to 8°C | Except | Folate: 4 days at 2 to 8°C
Estradiol: 5 days at 2 to 8°C |

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

2

Bio-Rad Laboratories 510 (k) Summary
Lloulchek Immunoassay Premium Control

: : · :

.

| Thawed Unopened

Stability		28 days at 2 to 8°C
	Except	Folate: 4 days at 2 to 8°C
Estradiol: 10 days at 2 to 8°C
Free PSA & Prolactin: 16 days at 2 to 8°C		Except		30 days at 2 to 8°C
Folate: 4 days at 2 to 8°C
Estradiol: 8 days at 2 to 8°C
Free PSA, PSA, Prolactin: 14 days at
2 to 8°C
		Total PSA: 17 days at 2 to 8°C
Frozen aliquot		28 days at -20 to -70 °C
	Analytes Include: Folate, Estradiol, Free PSA, Total PSA and Total Vitamin D
Analytes		Contains:				Contains:
		25-Hydroxy Vitamin D	•	Phenytoin, Free
Primidone
Procainamide
Progesterone
Prolactin
Prostatic Specific Antigen, Free
Prostate Specific Antigen, Total
Quinidine
Salicylate
T3 Uptake / T Uptake
T3, Free
T3, Total
T4, Free
T4, Total
Tricyclic Antidepressants Screen
Testosterone
Theophylline
Tobramycin
Thyroid Stimulating Hormone
Thyroxine Binding Globulin
Valproic Acid
Valproic Acid, Free
Vancomycin
Vitamin B12
Sex Hormone Binding Globulin
Beta-2-Microglobulin
CA 125
CA 15-3
CA 19-9		25-Hydroxy Vitamin D
Acetaminophen
Acid Phosphatase, Prostatic (PAP)
Alpha Fetoprotein
Amikacin
Caffeine
Carbamazepine
Carbamazepine, Free
Carcinoembryonic Antigen
Cortisol
Cyclosporine
Digoxin
Disopyramide
DHEA-Sulfate
Estradiol
Estriol, Free
Ethosuximide
Ferritin
Folate
Follicle Stimulating Hormone (FSH)
Gentamicin
hCG, Total beta
Human Growth Hormone
Immunoglobulin A
Immunoglobulin G
Immunoglobulin E
Immunoglobulin M
Insulin
Luteinizing Hormone
Lidocaine
Lithium
N-Acetylprocainamide
Phenobarbital
Phenytoin		T3, Total
T4, Free
T4, Total
Tricyclic Antidepressants Screen
Testosterone
Theophylline
Tobramycin
Thyroid Stimulating Hormone
Thyroglobulin
Thyroxine Binding Globulin
Valproic Acid
Valproic Acid, Free
Vancomycin
Vitamin B12
Sex Hormone Binding Globulin
17-Alpha
Hydroxyprogesterone
11-Deoxycortisol
Aldosterone
Amiodarone
Amitriptyline
Androstenedione
Angiotensin I
Antithyroid Peroxidase Antibodies
Antithyroglobulin antibody
Chloramphenicol
CK-MB Isoenzyme
Desipramine
Dehydroepiandrosterone
Estrogen, Total
Estriol, Total
Flecainide
Fructosamine
Human Chorionic Gonadotropin- Beta Subunit
Ibuprofen
Iron
Imipramine
Netilmicin
Propanolol
Parathyroid Hormone - MM
Somatomedin-C
Testosterone, Free
Total Iron Binding Capacity


	Does not Contain:			Estriol, Total
Flecainide
Fructosamine
Human Chorionic Gonadotropin- Beta Subunit
Ibuprofen
Iron
Imipramine
Netilmicin
Nortriptyline
Propanolol
Parathyroid Hormone - MM
Somatomedin-C
Testosterone, Free
	Desipramine Dehydroepiandrosterone Estrogen, Total	17-Alpha
Hydroxyprogesterone
11-Deoxycortisol
Aldosterone
Amiodarone
Amitriptyline
Androstenedione
Angiotensin I
Antithyroid Peroxidase Antibodies
Antithyroglobulin antibody
Carbamazepine, Free
Chloramphenicol
CK-MB Isoenzyme
Cyclosporine
Desipramine	Total Iron Binding Capacity Thyroglobulin		Does not Contain: Beta-2-Microglobulin CA 125		CA 15-3 CA 19-9

3

8.0 Statement of Supporting Data

Accelerated Stability studies have been performed to predict the Shelf life stability and real time studies were conducted to establish Thawed (opened and unopened) & Frozen aliquot claims for Liquichek Immunoassay Premium Control. Product claims are as follows:

Thawed Opened Stability:	14 days at 2 to 8°C (for most analytes)
Thawed Unopened Stability:	28 days at 2 to 8°C (for most analytes)
Frozen Aliquot	28 days at -20°C to -70°C
Shelf Life Stability:	28 Months at -20°C to -70°C (for most analytes)

The acceptance criteria for above studies is defined as the recovery result on final day (TFInal) being ± 10% of the recovery result of time zero vial (Tzero).

Real-time stability studies are ongoing to support the shelf life of this product.

9.0 Conclusion

Based on the performance characteristics indicated above, Liquichek immunoassay Premium Control is substantially equivalent to the predicate device (K001373).

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

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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.

Public Health Service

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

October 25, 2013

BIO-RAD LABORATORIES c/o Ms. Suzanne Parsons 9500 Jeronimo Rd. IRVINE CA 92618-2017

Re: K132227

Trade/Device Name: Liquichek Immunoassay Premium Control Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: September 25, 2013 Received: September 26, 2013

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 (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.

5

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 Small Manufacturers, International and Consumer Assistance 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 Small Manufacturers, International and Consumer Assistance 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.

Sincercly yours.

Carol C. Benson -S 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

6

Indications for Use

510(k) Number (if known): K132227

Device Name: Liquichek Immunoassay premium Control

Indication for Use:

Liquichek Immunoassay premium 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.

Prescription Use V And/Or (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Yung VF Dan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K132227