chemTRAK® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include chemTRAK® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol® H with patient serum specimens when assaying for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Description

This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various animal extracts and other non-protein materials including drugs, drug metabolites and purified chemicals. Amylase, ALT/GPT, AST/GOT, 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

The provided text describes a 510(k) premarket notification for assay controls, not an AI/ML device. Therefore, a significant portion of the requested information, which pertains to AI/ML device studies (e.g., sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance), is not applicable and not present in the document.

The document discusses the substantial equivalence of the Thermo Scientific MAS® chemTRAK® H and Moni-Trol® H Liquid Assayed Chemistry Controls to previously cleared predicate devices (K030942). The acceptance criteria and "study" in this context refer to demonstrating this substantial equivalence, primarily by comparing intended use, device description, matrix, storage conditions, and analyte lists.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not applicable or unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (quality control material), the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device, meaning it performs similarly and presents similar risks. The "reported device performance" is implicitly that it functions as a consistent test sample for monitoring assay conditions, akin to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Intended Use is substantially equivalent to predicate.	chemTRAK® H and Moni-Trol® H are intended for use as consistent test samples of known concentration for monitoring assay conditions in many clinical laboratory determinations, and to compare observations with expected ranges for consistent reagent and instrument performance. This is identical to the predicate's intended use.
Device Description is substantially equivalent to predicate (liquid stable control from human serum, adjusted analyte levels with animal extracts and non-protein materials, preservatives/stabilizers).	The modified device maintains the same description: a liquid stable control material prepared from human serum, with analyte levels adjusted using various animal extracts and other non-protein materials, and added preservatives and stabilizers. (Identical to predicate).
Matrix is substantially equivalent to predicate (human serum).	The modified device uses a liquid stable control material prepared from human serum. (Identical to predicate).
Storage Condition is substantially equivalent to predicate (-20°C).	The modified device storage condition is -20°C. (Identical to predicate).
Analyte list is substantially equivalent to predicate (minor modifications, but no new claims).	The modified device includes a very similar list of analytes to the predicate. New analytes are added, but "no claims are made" regarding them, implying they are not core to the equivalence claim for existing assays. Some analytes marked with * in the predicate device list are indicated as "not added, as found in the source material" for the modified device, implying their removal or non-addition does not affect the substantial equivalence of the core function.

2. Sample size used for the test set and the data provenance

Not applicable/provided. This device is a quality control material, not an AI/ML diagnostic tool requiring a test set of patient data. The "testing" involved demonstrating its characteristics and comparing them to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. "Ground truth" in the context of AI/ML diagnostics is not relevant here. The "truth" for this device lies in its chemical composition and its ability to act as a stable control with known concentrations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/provided. No adjudication method for a "test set" is relevant for this device.

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 is not an AI/ML device and no MRMC study was conducted or is relevant.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "truth" for this quality control material is its specified chemical composition and stability, which would be established through analytical chemistry and stability studies, not medical expert consensus or pathology on patient data.

8. The sample size for the training set

Not applicable/provided. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable/provided. This is not an AI/ML device.

Summary

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SEP 2 1 2009

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: K092051

COMPANY/CONTACT PERSON

Lisa Charter Manager, Regulatory Affairs Microgenics Corporation Thermo Fisher Scientific Specialty Diagnostics Division, CDx Fremont 46360 Fremont Blvd. Fremont, CA 94538 (510) 979-5142 office (510) 979-5422 fax

DATE PREPARED

July 16, 2009

DEVICE NAME

Trade Names:

Thermo Scientific MAS® chemTRAK® H Liquid Assayed Chemistry Controls Thermo Scientific Moni-Trol® H Liquid Assayed Chemistry Controls

Common Names:

chemTRAK® H Liquid Assayed Chemistry Controls Moni-Trol® H Liquid Assayed Chemistry Controls

Device Classification: Class | -

Classification Panel: Quality Control Material (Assayed and Unassayed) for Clinical Chemistry

Requlation number: 21 CFR 862.1660

Product Code: JJY

INTENDED USE:

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with expected ranges as a means of assuring consistent performance of reagent and instrument.

SUBSTANTIALLY EQUIVILANT PREDICATE DEVICE

Thermo Scientific MAS® chemTRAK® H and Thermo Scientific Moni-Trol® H are substantially equivalent to the previously cleared MAS® chemTRAK®H, DADE® Moni-Trol® H and OLYMPUS Chemistry Control (K030942)

DESCRIPTION OF DEVICE

Comparison	Predicate Device, K030942	Modified Device, K092051
Intended Use	chemTRAK® H is intended foruse as a consistent test sampleof known concentration formonitoring assay conditions inmany clinical laboratorydeterminations. IncludechemTRAK® H with patientserum specimens whenassaying for any of the listedconstituents. The user cancompare observations withexpected ranges as a means ofassuring consistentperformance of reagent andinstrument.	chemTRAK® H is intended foruse as a consistent test sampleof known concentration formonitoring assay conditions inmany clinical laboratorydeterminations. IncludechemTRAK® H with patientserum specimens whenassaying for any of the listedconstituents. The user cancompare observations withexpected ranges as a means ofassuring consistentperformance of reagent andinstrument.
	Moni-Trol® H is intended for useas a consistent test sample ofknown concentration for	Moni-Trol® H is intended for useas a consistent test sample ofknown concentration for

Description ofdevice	monitoring assay conditions inmany clinical laboratorydeterminations. Include Moni-Trol® H with patient serumspecimens when assaying forany of the listed constituents.The user can compareobservations with expectedranges as a means of assuringconsistent performance ofreagent and instrument.	monitoring assay conditions inmany clinical laboratorydeterminations. Include Moni-Trol® H with patient serumspecimens when assaying forany of the listed constituents.The user can compareobservations with expectedranges as a means of assuringconsistent performance ofreagent and instrument.
Matrix	This product is a liquid stablecontrol material prepared fromhuman serum.	This product is a liquid stablecontrol material prepared fromhuman serum.
StorageCondition	-20°C	-20°C

Comparison of Technological Characteristics

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AnalyteList	Predicate DeviceK030942	Modified DeviceProposed Analytes(Modifications in bold)
	Acetaminophen	Acetaminophen
	Acid Phosphatase*	Acid Phosphatase*
	Albumin	Albumin
	Alkaline Phosphatase, ALP	Alkaline Phosphatase, ALP
	Alanine Aminotransferase, ALT	Alanine Aminotransferase, ALT
	Alpha-Fetoprotein, AFP*	Alpha-Fetoprotein, AFP*
	Amikacin	Amikacin
Analyte	Amylase	Amylase
List, Cont.	Apolipoprotein A (APO A)*	Apolipoprotein A (APO A) *
	Apolipoprotein B (APO B)*	Apolipoprotein B (APO B) *
	Aspartate Aminotransferase, AST	Aspartate Aminotransferase, AST
	Bilirubin, Direct	Bilirubin, Direct
	Bilirubin, Total	Bilirubin, Total
	Blood Urea Nitrogen, BUN	Blood Urea Nitrogen, BUN
	Caffeine	Caffeine
	Calcium	Calcium
	Carbamazepine	Carbamazepine
	Carbon Dioxide, CO2	CO2
	C3 Compliment	C3 Complement*
	C4 Compliment	C4 Complement*
	C-Reactive Protein, CRP	C-Reactive Protein, CRP*
	Chloride	Chloride
	Cholesterol	Cholesterol
	Creatine Kinase, CK	Creatine Kinase, CK
	Creatinine	Creatinine
	Cyclosporine*
	Digoxin	Digoxin
	Disopyramide	Disopyramide
	Ethanol	Ethanol
	Ethosuximide	Ethosuximide
	Ferritin	Ferritin*
	Thiiodothyronine Free T3	Thiiodothyronine Free T3*
	Thyroxine Free T4	Thyroxine Free T4*
	Gamma Glutamyltransferase, GGT	Gamma Glutamyltransferase, GGT
	Gentamicin	Gentamicin
	Glutamate Dehydrogenase,	Glutamate Dehydrogenase,
	GLDH*	GLDH*
	Glucose	Glucose
	Haptoglobin*	Haptoglobin*
	Hydroxybutyrate Dehydrogenase,HBDH*	Hydroxybutyrate Dehydrogenase,HBDH*
	High Density Lipoprotein	High Density Lipoprotein
	Cholesterol, HDL	Cholesterol, HDL
	Human Chorionic Gonadotrophin,hCG	Human Chorionic Gonadotrophin,hCG*
	Immunoglobulin A, IgA	Immunoglobulin A, IgA*
	Immunoglobulin G, IgG	Immunoglobulin G, IgG*
	lmmunoglobulin M, IgM	lmmunoglobulin M, IgM*
	Iron	Iron
	Lactate Dehydrogenase, LDH	LDH
	Lactic Acid	Lactic Acid
	Lidocaine	Lidocaine
AnalyteList,Cont.	Lipase	LipaseLipoprotein (LpA)*
	Lithium	Lithium
	Low Density LipoproteinCholesterol, LDL	LDL-Cholesterol
	Magnesium	Magnesium
	Methotrexate	Methotrexate
	N-Acetylprocainamide, NAPA	N-Acetylprocainamide, NAPA
	Osmolality	Osmolality
	Phenobarbital	Phenobarbital
	Phenytoin	Phenytoin
	Phosphorus	Phosphorus
	Potassium	Potassium
	Prealbumin	Prealbumin
	Primidone	Primidone
	Procainamide	Procainamide
	Prostate Specific Antigen, PSA	-
	Pseudocholinesterase, PCHE	Pseudocholinesterase
	Quinidine	Quinidine
	Salicylate	Salicylate
	Sodium	Sodium
	Theophylline	Theophylline
	Thyroid Stimulating Hormone, TSH	Thyroid Stimulating Hormone, TSH
	Thyroxine, Total T4	Thyroxine, Total T4
	Tobramycin	Tobramycin
	Total Iron Binding Capacity, TIBC	Iron Binding Capacity, Total
	Total Protein	Total Protein
	Transferrin	Transferrin*
	Tricyclic Antidepressants	Tricyclic Antidepressants
	Triglycerides	Triglycerides
	Thiiodothyronine, Total T3	Thiiodothyronine, Total T3*
	T-Uptake	T-Uptake
	Uric Acid	Uric Acid
	Valproic Acid	Valproic Acid
	Vancomycin	Vancomycin
	Unsaturated Iron Binding Capacity(UIBC)	Unsaturated Iron Binding Capacity(UIBC)*

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and the comments of the comments of the comments of

1999 - 1999 - 1999

{4}------------------------------------------------

Analytes are added, however no claims are made

. . . .

♦ Analytes are not added, as found in the source material.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

MicroGenics Corporation. Thermo Fisher Scientific c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538

SEP 2 1 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

· Re: K092051

Trade Name: Thermo Scientific MAS® chemTRAK® H Liquid Assayed Chemistry Controls, Thermo Scientific Moni-Trol® H Liquid Assayed Chemistry Controls

Regulation Number: 21 CFR §862.1660

Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I, reserved

Product Codes: JJY

Dated: July 1. 2009

Received: July 7, 2009

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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. Acting 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: K092051

Device Name:

Thermo Scientific MAS® chemTRAK® H Liquid Assayed Chemistry Controls Thermo Scientific Moni-Trol® H Liguid Assayed Chemistry Controls

Indication For Use:

Moni-Trol® H is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Include Moni-Trol® H with patient serum specimens when assaving for any of the listed constituents. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Prescription Use

And/Or

Over the Counter Use

(21 CFR Part 801 Subpart D) Subpart C)

(21 CFR Part 801

(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)

Carol Benson

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

510(k) k.092051

Page 1 of 1

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.