Liquid Assayed Multiqual Premium 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.

Device Description

This product is prepared from human serum to which purified biochemical (tissue extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is provided in liquid form for convenience.

AI/ML Overview

This document is a 510(k) summary for the Bio-Rad Laboratories Liquid Assayed Multiqual Premium. It describes a quality control material intended to monitor the precision of laboratory testing procedures.

The study presented focuses solely on the stability of the device itself, as its intended use is to serve as a quality control material. Therefore, typical acceptance criteria and study designs for diagnostic or AI-powered devices (e.g., sensitivity, specificity, MRMC studies, ground truth established by experts/pathology) are not applicable to this type of device.

Here's the information gleaned from the submission regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

Stability Type	Acceptance Criteria (Stated Claim)	Reported Device Performance (Confirmed by Study)
Shelf Life Stability	"3 Years at -20 to -70 ℃"	"Acceptance criteria were met to support product as claimed." (Based on Accelerated Stability studies)
Thawed & Unopened Vial Stability	"All analytes will be stable for 30 days when the control material is thawed and stored unopened at 2 to 8°C, with the following exceptions: Direct Bilirubin will be stable for 11 days, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (From Table 1, Predicate) Note: The new device claims "All analytes will be stable for 14 days...exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." and the text in Section 8 repeats the 14-day claim.	"All analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (Based on Real Time Stability studies; there is a discrepancy between the text in Section 8 and the table for the general stability period claim)
Thawed & Opened Vial Stability	"Once the product stopper is punctured, all analytes will be stable for 5 days when stored at 2 to 8°C." (From Table 1, Predicate) Note: The new device claims "all analytes will be stable for 14 days...exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days."	"All analytes will be stable for 14 days when stored tightly capped at 2 to 8℃, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days." (Based on Real Time Stability studies)
Frozen Aliquot Stability	"No claims made." (From Table 1, Predicate)	"AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, and Triglycerides will be stable for 14 days when stored in tightly capped aliquot amber vials at -20 to -70°C." (Based on Real Time Stability studies)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "replicate analyses" and "a representative sampling of this lot of product" for value assignment, and "Real Time Stability studies" and "Accelerated Stability studies" for stability claims. However, specific numbers of samples or batches tested are not provided.
Data Provenance: The studies were conducted by Bio-Rad Laboratories or "independent laboratories." The data appears to be prospective as it's generated specifically for the stability claims being made for this new device. The country of origin for the data is not specified, but Bio-Rad Laboratories is located in Irvine, California, USA, implying the studies were likely conducted there or overseen by their US operations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This device is a quality control material, not a diagnostic or AI device that requires expert interpretation for its "ground truth" performance in a clinical setting. The "ground truth" in this context pertains to the stability of the analytes within the control material, which is determined by analytical measurements against established reference methods, not expert consensus.
The "Value Assignment" section states that "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." This indicates analytical testing and interlaboratory data were used to assign values, not expert opinions.

4. Adjudication Method for the Test Set

Not Applicable. As this is a quality control material stability study, there is no "adjudication method" in the sense of resolving discrepancies in expert interpretations. The stability is determined by meeting pre-defined analytical criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not applicable to a quality control material. MRMC studies are used for evaluating diagnostic performance (e.g., image interpretation) where human readers are involved.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. This is a chemical control material, not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device is the analytical stability of the constituents (analytes) over time and under various storage conditions. This is established through analytical testing using manufacturer-supported reagents and representative samples of the product. The acceptance criteria for stability (e.g., within certain limits or recovery percentages relative to initial measurements) likely guide the determination of whether the analytes are "stable."

8. The Sample Size for the Training Set

Not Applicable. This is not an AI or machine learning device that requires a "training set." The product's characteristics are determined through analytical chemistry and stability testing.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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510(k) Summary Liquid Assayed Multiqual Premium

MAR 01 2013

1.0 Submitter

130162

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

Date of Summary Preparation

February 26, 2013

2.0 Device Identification

Product Trade Name:	Liquid Assayed Multiqual Premium
Common Name:	Multi-Analyte Controls, All Kinds (Assayed)
Classifications:	Class I, Reserved
Product Code:	JJY
Regulation Number:	21 CFR 862.1660

Device to Which Substantial Equlvalence is Claimed 3.0

Predicate Device Information
Device Name:	Liquid Assayed Multiqual
Applicant:	Bio-Rad Laboratories
510(k) Number:	K100727
Product Code:	JJY
Regulation #:	862.1660
Device Classification Name:	Multi-analyte Controls All Kinds(Assayed)

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???" 4.0 Description of Device

Table 1: Product Catalog DescriptIon

Description	Configuration
Liquid Assayed Multiqual Premium, Level 1	6 x 5 mL
Liquid Assayed Multiqual Premium, Level 2	6 x 5 mL
Liquid Assayed Multiqual Premium, Level 3	6 x 5 mL
Liquid Assayed Multiqual PremiumTrilevel MiniPak	3 x 5 mL(1 per level)

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. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.

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.

The data printed in our package insert meet our internal processes and procedure requirements for the assignment of values.

6.0 Intended Use

Liquid Assayed Multiqual Premium is intended for use as an assaved quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

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Comparison of the new device with the Predicate Device 7.0

Liquid Assayed Multiqual Premium is substantially equivalent to Liquid Assayed Multiqual currently in commercial distribution under 510(k) K100727. Table 1 (below) indicates similarities and differences between the new and predicate device.

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

	Liquid Assayed Multiqual Premlum		Liquid Assayed Multiqual
	(New Device)		(Predicate Device - 510(k) cleared under K100727)
	Similarities
Intended Use	Liquid Assayed Multiqual Premium is intended for use as anassayed quality control serum to monitor the precision oflaboratory testing procedures for the analytes ilsted in thepackage Insert.		Llould Assayed Multiqual is intended for use as an assayedquality control serum to monitor the precision of laboratorytesting procedures for the analytes listed In the package insert.
Matrix	Human Serum		Human Serum
Form	Liquid		Liquid
	Differences
Analytes	Contains:		Contains:
	AcetamInophen	Haptoglobin	Acetaminophen	Immunoglobulin M (IgM)
	Acid Phosphatase	İmmunoglobulin A (IgA)	Alanine Aminotransferase(ALT/SGPT)	lron
	AlanineAmInotransferase(ALT/SGPT)	Immunoglobulin G (IgG)	AlbumIn	Iron Binding Capacity, Total(TIBC)
	Albumin	Immunoglobulln M (IgM)	Alkaline Phosphatase (ALP)	Lactate (Lactic Add)
	Alkaline Phosphatase (ALP)	lron	Alpha-1-Antitrypsin	Lactate Dehydrogenase(LDH)
	Alpha-1-Acld Glycoprotein	Iron Binding Capacity,Total (TIBC)	Amylase	Lipase
	Alpha-1-Antitrypsin	Iron Binding Capacity,Unsaturated (UIBC)	Apollpoproteln A-1	Lithlum
	Alpha-HydroxybutyrateDehydrogenase (aHBDH)	Kappa Light Chalns	Apolipoprotein B	Magnesium
	Amikacin	Lactate (Lactic Acid)	Aspartate Aminotransferase(AST/SGOT)	Phenobarbital
	Amylase	Lactate Dehydrogenase(LDH)	Bilirubin, Direct	Phenytoln
	Amylase, Pancreatic	Lambda Light Chains	Bilirubin, Total	Phosphorus
	Antl-CCP	Lidocaine	C3 Complement	Potasslum
	Apollpoprotein A-1	Lipase	C4 Complement	Prealbumin
	Apolipoproteln B	Lithlum	Calclum, Total	Proteln, Total
	ASO	Magneslum	Carbamazepine	Sallcylate
	Aspartate Aminotransferase(AST/SGOT)	Methotrexate	Carbon Dioxide (CO2)	Sodlum
	Beta-2-Microglobulin	NAPA	Ceruloplasmin	T3 Total
	Bile AcidsBillrubin, Direct	Osmolality	Chloride	T3 Uptake/T-Uptake
		Phenobarbital	Cholesterol, High DensityLipoprotein (HDL)	T4 Free
	Billrubin, Total	Phenytoin	Cholesterol, Low DensityLipoprotein (LDL)	T4 Total
	Bilirubin, Neonatal	Protein Electrophoresis	Cholesterol, Total	Theophylline
	C3 Complement	Phosphollplds	Creatine Kinase (CK)	Thyroid Stimulating Hormone(TSH)
	C4 Complement	Phosphorus	Creatinine	Tobramycin
	Caffeine	Potasslum	Digoxin	Transferrin
	Calcium, Ionized	Prealbumin	Ethanol	Triglycerides
	Calcium. Total	Procalnamide	Ferritin	Urea Nitrogen (BUN)
	Carbamazepine	Proteln, Total	Gamma Glutamyltransferase(GGT)	Uric Acid

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	Carbon Dioxide (CO2)	Glucose	Gentamicin	Valproic Acid
	Ceruloplasmin	Quinidine	Glucose	Vitamin B12
	Chloride	Salicylate	Haptoglobin	Pseudocholinesterase
	Cholesterol, High Density	Sodium	Immunoglobulin A (IgA)
	Lipoprotein (HDL)
	Cholesterol, Low Density	T3 Total	Immunoglobulin G (IgG)
	Lipoprotein (LDL)
	Cholesterol, Total	T3 Uptake/T-Uptake
	Cholinesterase	T4 Free	Does not contain:
	Copper	T4 Total	Acid Phosphatase	Iron Binding Capacity,Unsaturated (UIBC)
	Cortisol	Theophylline	Alpha-1-Acid Glycoprotein	Kappa Light Chains
	Creatine Kinase (CK)	Thyroid StimulatingHormone (TSH)	Alpha-HydroxybutyrateDehydrogenase (aHBDH)	Lambda Light Chains
	Creatinine	Tobramycin	Amikacin	Lidocaine
	CRP	Transferrin	Amylase, Pancreatic	Methotrexate
	Cystatin C	Triglycerides	Anti-CCP	NAPA
	Digoxin	Urea	ASO	Osmolality
	Disopyramide	Urea Nitrogen (BUN)	Beta-2-Microglobulin	Phospholipids
	Ethanol	Uric Acid	Bile Acids	Procainamide
	Ferritin	Valproic Acid	Bilirubin, Neonatal	Protein Electrophoresis
	Gamma Glutamyltransferase(GGT)	Vancomycin	Caffeine	Quinidine
	Gentamicin	Vitamin B12	Calcium, Ionized	Triglycerides
	Globulin	Zinc	CRP	Urea
	Does not contain:		Cystatin C	Uric Acid
	Pseudocholinesterase		Globulin	Vancomycin
Shelf StorageStability	Until expiration date at -20 to -70 °C		Until expiration date at -20 to -50 °C
Thawed &Unopened VialStability	When the control material Is thawed and stored unopened at2 to 8°C, all analytes will be stable for 30 days with thefollowing exceptions: Direct Bilirubin will be stable for 11days, Triglycerides, HDL, Cholinesterase, and Phosphoruswill be stable for 7 days.		When this product is stored at 2 to 8°C unopened and thestopper is not punctured, all analytes will be stable for 30 dayswith the following exceptions: Direct Bilirubin will be stable for11 days, Triglycerides, HDL, Pseudocholinesterase andPhosphorus will be stable for 7 days. This product can be usedfor 7 days when stored on-board the Siemens Dimension Vistaat 2 to 8°C,
Thawed andOpened VialStability	Once the control material Is thawed and opened, all analyteswill be stable for 14 days when stored tightly capped at 2 to8°C, with the following exceptions: Direct Bilirubin,Triglycerides, HDL, Cholinesterase, and Phosphorus will bestable for 7 days.		Once the product stopper is punctured, all analytes will bestable for 5 days when stored at 2 to 8°C.
Frozen AliquotStability	AST/SGOT, Direct Bilirubin, HDL, Phosphorus, LDL, andTriglycerides will be stable for 14 days when stored in tightlycapped aliquot amber vials at -20 to -70°C.		No claims made.
Fill Size	5 mL		2.5 mL

8.0 Statement of Supporting Data

Real Time Stability studies were conducted to establish thawed (opened and unopened vial) stability and frozen aliquot stability claims. Accelerated Stability studies were conducted to establish the shelf life stablity claims. Acceptance criteria were met to support product as claimed:

・

Thawed and Opened Vial Stability: All analytes will be stable for 14 days when stored tightly capped at 2 to 8℃, with the following exceptions: Direct Bilirubin, Triglycerides, HDL,

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Cholinesterase, and Phosphorus will be stable for 7 days.

stored in tightly capped aliquot amber vials at -20 to

Thawed and Unopened Vial Stability: All analytes will be stable for 14 days when stored tightly capped at 2 to 8°C, with the following exceptions: Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus will be stable for 7 days. Frozen Aliquot Stabillty: AST/SGOT, Direct Bilirubln, HDL, Phosphorus, LDL, and Triglycerides will be stable for 14 days when
-70°C.

Shelf life Stability: 3 Years at -20 to -70 ℃

9.0 Conclusion

Based on the performance characteristics indicated above, Liquid Assayed Multiqual i Premium Control is substantially equivalent to the predicate device.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 1, 2013

Bio-Rad Laboratories c/o Suzanne Parsons 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K130162

Trade/Device Name: Liquid Assayed Multiqual Premium Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, Reserved Product Code: JJY Dated: January 21, 2013 Received: January 23, 2013

Dear Ms. Suzanne 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 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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Page 2 - Suzanne Parsons

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours,
Carol C. Benson - for
S FDA

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): K130162

Device Name: Liquid Assayed Multiqual Premium

Indications for Use:

Liquid Assayed Multiqual Premium 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 X (21 CFR Part 801 Subpart D) And/Or

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)

YungWDChan-S

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

K130162 510(k)_

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.