Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS® Omni•CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Description

Omni•CORE is a liquid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, CK and Lipase are obtained from porcine tissue; alkaline phosphatase and GGT are from bovine tissue; LDH is from avian tissue. Preservatives and stabilizers are added to maintain product integrity.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the MAS® Omni•CORE device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K110738) is a 510(k) summary for a Quality Control Material (QCM), not a diagnostic device or an AI-powered system that would typically have performance metrics like sensitivity, specificity, or accuracy. Therefore, the concept of "acceptance criteria" and "reported device performance" as applied to accuracy/effectiveness for an AI or diagnostic device does not directly apply here in the traditional sense.

Instead, the "acceptance criteria" for a QCM generally revolve around its intended use, matrix, form, control levels, storage, shelf life, and the analytes it covers, ensuring it is substantially equivalent to existing QCMs. The "reported device performance" is essentially the description of MAS® Omni•CORE's characteristics that demonstrate this equivalence.

Here's how we can frame it based on the available information:

Acceptance Criteria (Implied for Substantial Equivalence to Predicates)	Reported Device Performance (MAS® Omni•CORE)
Intended Use: For monitoring assay conditions in clinical laboratory determinations.	Intended Use: "Thermo Scientific MAS® Omni•CORE™ is intended for use as an assayed control for monitoring assay conditions in many clinical laboratory determinations. Include MAS® Omni•CORE with patient serum specimens when assaying for any of the constituents. Assay values are provided for the specific systems listed. The user can compare observations with their expected ranges as a means of assuring consistent performance of reagent and instrument." (Matches predicates closely).
Matrix: Human Serum	Matrix: Human Serum (Matches predicates)
Form: Liquid / Frozen Liquid	Form: Frozen Liquid (Matches Predicate 1, differs from Predicate 2 which is just "Liquid")
Control Levels: Multiple levels (e.g., Level 1, Level 2, Level 3)	Control Levels: Level 1, Level 2, Level 3 (Matches both predicates)
Storage: Appropriate for stability	Storage: -20°C (Matches Predicate 1, differs from Predicate 2 which is 2-8°C)
Shelf Life: Comparable to existing QCMs	Shelf Life: 3 years (Longer than Predicate 1 (2.5 years) and Predicate 2 (2 years))
Analytes by Configuration: Covers a wide range of common clinical chemistry analytes.	Analytes by Configuration: MAS® Omni•CORE covers a very extensive list of analytes, encompassing and expanding upon the analytes offered by the predicate devices MAS® ChemTRAK H and MAS® Immunology Control. This is demonstrated by the extensive lists provided on pages 3 and 4 of the document.

Study Proving Device Meets Acceptance Criteria:

The "study" presented here is a substantial equivalence comparison to legally marketed predicate devices. The document explicitly states: "As summarized, Omni-CORE is substantially equivalent to the previously [cleared] chem-TRAK H (K09205) and MAS Immunology (K960824) Controls."

This type of submission primarily relies on demonstrating that the new device has the same intended use and similar technological characteristics as the predicates, and that any differences do not raise new questions of safety or effectiveness. For a quality control material, this typically involves:

Analytical Performance Studies: While not detailed in this summary, a QCM would undergo internal testing to establish the target values and acceptable ranges for each analyte across various common laboratory instruments and methods. These studies demonstrate that the control material performs as expected for its intended use (i.e., that it provides stable, known-concentration samples for monitoring assay conditions).
Stability Studies: To support the claimed shelf life and open-vial stability.
Homogeneity Studies: To ensure uniform concentration throughout the batch.
Value Assignment Studies: To determine the assayed values for various instruments and methods.

The summary provided does not contain the detailed data from these studies. Instead, it presents the conclusion drawn from such studies, which is the affirmation of substantial equivalence based on matching or similar characteristics.

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

Sample Size for Test Set: Not explicitly stated in the 510(k) summary. For a quality control material, the "test set" would refer to the number of individual control vials or batches tested during value assignment, stability, and homogeneity studies. This information is typically found in the full submission, not the summary.
Data Provenance: Not explicitly stated. For internal validation studies of a quality control material, the data would typically be generated in-house by the manufacturer (Thermo Fisher Scientific / Microgenics Corporation) in their own laboratories. It is not patient data, but rather data generated from testing the control material itself. Therefore, concepts like "country of origin of the data" (in terms of patient demographics) or "retrospective/prospective" (in relation to patient enrollment) are not directly applicable.

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

This question is not applicable to a Quality Control Material like MAS® Omni•CORE.

"Ground truth" for a QCM is established through rigorous analytical chemistry and metrology. The "true" concentration of an analyte in the control material is determined through highly accurate reference methods, often by multiple independent analyses or by comparison to certified reference materials. It does not involve human expert interpretation of images or clinical data.
Therefore, there were no "experts" in the sense of clinicians or radiologists establishing a subjective "ground truth." The ground truth for analyte concentrations is objectively determined experimentally.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for analyte concentrations in a QCM is determined objectively through analytical methods, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a quality control material for laboratory assays, not an AI-powered diagnostic device that assists human readers. No MRMC study was performed.

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

Not applicable. This device is a laboratory reagent, not an algorithm or software device.

7. The Type of Ground Truth Used

The ground truth for the MAS® Omni•CORE (target values for each analyte) would be established through a combination of:

Reference Methods: Using highly accurate and precise analytical methods (often recognized reference methods) to determine the concentration of each analyte in the control material.
Comparison to Certified Reference Materials: Where available, direct comparison or traceability to certified reference materials.
Consensus from Multiple Assays/Instruments: For assayed controls, values are often assigned based on analysis across multiple common laboratory instruments and reagent systems, generating a consensus or assigned range.

It is not based on expert consensus (clinical opinion), pathology (histology), or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a "training set." The materials used to produce the control (human serum base, animal extracts, purified chemicals, etc.) are raw materials, not a training set in the computational sense.

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

Not applicable. As there is no "training set" for an AI algorithm, there is no ground truth established for it in this context. The "ground truth" for the actual control material, as described in point 7, is established through analytical testing.

Summary

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510K SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92

The assigned 510(k) number is: K110738

Company/Contact person

Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 Office (510) 979-5422 Fax Lisa. Charter@thermofisher.com

Date Prepared

October 31, 2011

Regulatory Declarations

Common / Usual Name	MAS® Omni•CORE
Trade/ Proprietary Name	Thermo Scientific MAS® Omni•CORE
Classification Regulation	21 CFR 862.1660 – Quality control material (assayed and unassayed)
Device Class	Class I
Device Regulation Panel	Clinical Chemistry
Product Code	JJY

Intended use

Legally marketed device to which equivalency is claimed

MAS® Omni•CORE is substantially equivalent to the previously cleared MAS® Chem-TRAK H (K092051) and MAS® Immunology (K960824) Controls.

Fremont, CA
94538-6406

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Description of Device

The control is offered in three levels with the following configuration:

	MAS® Omni-CORE
Catalog Number	Description	Size
OCORE-101	Level 1	6 vials of Level 1, 5 mLs per vial
OCORE-202	Level 2	6 vials of Level 2, 5 mLs per vial
OCORE-303	Level 3	6 vials of Level 3, 5 mLs per vial
OCORE-SP	Sample-pack	1 vial of Level 1, 5 mLs per vial1 vial of Level 2, 5 mLs per vial1 vial of Level 3, 5 mLs per vial

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ThermoFisher

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Comparison of Technological Characteristic

Comparison	Subject Device	Predicate 1	Predicate 2
Device	MAS® Omni-CORE	MAS® ChemTRAK H	MAS® Immunology Control
510(k) number	K110738	K092051	K960824
Intended Use	Thermo Scientific MAS® Omni-CORETM isintended for use as an assayed control formonitoring assay conditions in many clinicallaboratory determinations. Include MAS®Omni-CORE with patient serum specimenswhen assaying for any of the constituents.Assay values are provided for the specificsystems listed. The user can compareobservations with their expected ranges as ameans of assuring consistent performance ofreagent and instrument.	chemTRAK® H is intended for use as aconsistent test sample of known concentrationfor monitoring assay conditions in many clinicallaboratory determinations. Include chemTRAK®H with patient serum specimens when assayingfor any of the listed constituents. The user cancompare observations with expected ranges asa means of assuring consistent performance ofreagent and instrument.Moni-Trol® H is intended for use as a consistenttest sample of known concentration formonitoring assay conditions in many clinicallaboratory determinations. Include Moni-Trol® Hwith patient serum specimens when assayingfor any of the listed constituents. The user cancompare observations with expected ranges asa means of assuring consistent performance ofreagent and instrument.	Immunology Control is intended for use inthe clinical laboratory as a consistent testsample of known concentration for-monitoring assay conditions in manyimmunological determinations. IncludeImmunology control with patient serumspecimens when assaying for any of thelisted constituents. The user can compareobservations with expected ranges as ameans of assuring consistent performance ofreagent and instrument.
Matrix	Human Serum	Human Serum	Human Serum
Form	Frozen Liquid	Frozen Liquid	Liquid
Control Levels	Level 1Level 2Level 3	Level 1Level 2Level 3	Level 1Level 2Level 3
Storage	-20°C	-20°C	2-8°C
Shelf Life	3 years	2.5 year	2 years
Analytes byConfiguration	AcetaminophenAlbuminALK Phos. (Alkaline Phosphatase)alpha-1-Acid Glycoproteinalpha-1-Antitrypsinalpha-2-MacroglobulinALT	AcetaminophenAcid PhosphataseAlbuminAlkaline Phosphatase, ALPAlanine Aminotransferase, ALTAlpha-Fetoprotein, AFPAmikacin	Albuminalpha-1-Acid Glycoproteinalpha-1-Antitrypsinalpha-2-MacroglobulinAntistreptolysinAntithrombin IIIApolipoprotein A

ww.thermofisher.com
www.microgenics.com 510-979-5000
510-979-5002 fax

46360 Fremont Blvd

Fremont, CA
94538-6406

Diagnostics Division
Microgenics Products

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ThermoFisher

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in serving science

Amikacin	Amylase	Apolipoprotein B
Amylase	Apolipoprotein A (APO A)	Beta 2 Microglobulin
Antistreptolysin O (ASO)	Apolipoprotein B (APO B)	C3 Complement
Apolipoprotein A1	Aspartate Aminotransferase, AST	C4 Complement
Apolipoprotein B	Bilirubin, Direct	Ceruloplasmin
AST	Bilirubin, Total	C-Reactive Protein
Beta 2 Microglobulin	Blood Urea Nitrogen, BUN	Haptoglobin
Bile Acids	C3 Complement*	Immunoglobulin A
Bilirubin, Direct (DBIL)	C4 Complement*	Immunoglobulin E
Bilirubin, Total (BILT)	Caffeine	Immunoglobulin G
BUN	Calcium	Immunoglobulin M
C3 Complement	Carbamazepine	Kappa Light Chain
C4 Complement	Chloride	Lamda Light Cha
Caffeine	Cholesterol	Prealbumin
Calcium	Creatine Kinase, CK	Properidin Factor B
Carbamazepine	CO2	Rheumatoid Factor
Ceruloplasmin	C-Reactive Protein, CRP*	Total Protein
Chloride	Creatinine	Transferrin
Cholesterol	Digoxin
CK	Disopyramide
CO2	Ethanol
Copper	Ethosuximide
Cortisol	Ferritin*
C-Reactive Protein (CRP)	Gentamicin
Creatinine	Gamma Glutamyltransferase, GGT
Digoxin	Glucose
Disoprymide	Glutamate Dehydrogenase, GLDH*
Ethanol	Haptoglobin*
Ethosuximide	Hydroxybutyrate Dehydrogenase, HBDH*
Ferritin	High Density Lipoprotein Cholesterol, HDL
Gentamicin	Human Chorionic Gonadotrophin, hCG*
GGT	Immunoglobulin A, IgA*
Glucose	Immunoglobulin G, IgG*
Haptoglobin	Immunoglobulin M, IgM*
HDL Cholesterol	Iron
IgA	Iron Binding Capacity, Total
IgE	Lactic Acid
IgG	LDH
IgM	LDL-Cholesterol
Iron	Lidocaine

Diagnostics Division
Microgenics Products

న

www.thermofisher.com
www.microgenics.com

510-979-5000
510-979-5002 fax

Fremont, CA
94538-6406

46360 Fremont Blvd

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ThermoFisher

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in serving science

Iron Binding Capacity, Total (TIBC)	Lipase
Lactic Acid	Lipoprotein (LPA)
LDH	Lithium
LDL-Cholesterol	Magnesium
Lidocaine	Methotrexate
Lipase	N-Acetylprocainamide, NAPA
Lipoprotein (a)	Osmolality
Lithium	Phenobarbital
Magnesium	Phenytoin
Methotrexate	Phosphorus
NAPA	Potassium
Osmolality	Prealbumin
Phenobarbital	Primidone
Phenytoin	Procainamide
Phosphorus	Pseudocholinesterase
Potassium	Quinidine
Prealbumin	Salicylate
Primidone	Sodium
Procainamide	Thyroxine Free T4*
Pseudocholinesterase (PCHE)	Thyroxine, Total T4
Quinidine	Theophylline
Rheumatoid Factor (RF)	Thyroid Stimulating Hormone, TSH
Salicylate	Tobramycin
Sodium	Total Protein
Thyroxine, Total T4	Transferrin*
Theophylline	Triglycerides
Thyroid Stimulating Hormone, TSH	Tricyclic Antidepressants
Tobramycin	Thiiodothyronine, Total T3*
Total Protein	Thiiodothyronine Free T3*
Transferrin	T-Uptake
Triglycerides	Unsaturated Iron Binding Capacity (UIBC)*
Tricyclic Antidepressants (TCA)	Uric Acid
T-Uptake	Valproic Acid
Unsaturated Iron Binding Capacity (UIBC)	Vancomycin
Uric Acid
Valproic Acid
Vancomycin
Zinc

Diagnostics Division
Microgenics Products

46360 Fremont Blvd

Fremont, CA
94538-6406

510-979-5000
510-979-5002 fax

www.themofisher.com
www.microgenics.com

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hermoFisher . S

The world leader
in serving science

Conclusion

As summarized, Omni-CORE is substantialy equivalent to the previously chem-TRAK H (K09205) and MAS
lmmunology (K960824) Controls. Substantial equivalence has been satsified.

Diagnostics Division
Microgenics Products

ﻟﺴﻨﺔ

ww.thermofisher.com

510-979-5000
510-979-5002 fax

Fremont, CA
94538-6406

16360 Fremont Blvc

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

NOV 03 2011

Microgenics Corporation c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538

Re: K110738 Trade Name: Thermo Scientific MAS® Omni-Core Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I, Reserved Product Codes: JJY Dated: September 15, 2011 Received: September 20, 2011

Dear Ms. Charter:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.goy/MedicalDevicesforYou/Industry/default.htm.

Sincerely yours,

signature

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known): K110738

Device Name: MAS® Omni•CORE

Indication for Use:

Prescription Use X (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 Diagnostic Device Evaluation and Safety (OIVD)

And/Or

CARS

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110738

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.