THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158

K092051 · Microgenics Corp. · JJY · Sep 21, 2009 · Clinical Chemistry

Device Facts

• Record ID: K092051
• Device Name: THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158
• Applicant: Microgenics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

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 Story

Liquid stable control material derived from human serum; supplemented with animal extracts, drugs, metabolites, and purified chemicals. Used in clinical laboratories to monitor assay performance by comparing observed values against expected ranges. Operates as a consistent test sample for various clinical chemistry analyzers. Provides quality assurance for reagent and instrument performance. Does not provide diagnostic output; serves as a reference standard for laboratory quality control workflows.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid stable control material; human serum matrix; analytes adjusted with porcine, bovine, and avian tissue extracts; includes preservatives and stabilizers. Storage at -20°C. No software or electronic components.

Indications for Use

Indicated for use as a quality control material for monitoring assay performance in clinical laboratory determinations. Used by clinical laboratory professionals to verify reagent and instrument consistency by comparing observed values of specific analytes against expected ranges in human serum-based samples.

Regulatory Classification

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.

Predicate Devices

• MAS® chemTRAK® H (k030942)
• Dade Moni-Trol® H (k030942)
• Olympus Chemistry Control (k030942)

Submission Summary (Full Text)

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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 [phone] office [phone] 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:

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

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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.

## 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

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.

| Comparison | Predicate Device, K030942 | Modified Device, K092051 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | chemTRAK® H is intended for<br>use as a consistent test sample<br>of known concentration for<br>monitoring assay conditions in<br>many clinical laboratory<br>determinations. Include<br>chemTRAK® H with patient<br>serum specimens when<br>assaying for any of the listed<br>constituents. The user can<br>compare observations with<br>expected ranges as a means of<br>assuring consistent<br>performance of reagent and<br>instrument. | chemTRAK® H is intended for<br>use as a consistent test sample<br>of known concentration for<br>monitoring assay conditions in<br>many clinical laboratory<br>determinations. Include<br>chemTRAK® H with patient<br>serum specimens when<br>assaying for any of the listed<br>constituents. The user can<br>compare observations with<br>expected ranges as a means of<br>assuring consistent<br>performance of reagent and<br>instrument. |
| | Moni-Trol® H is intended for use<br>as a consistent test sample of<br>known concentration for | Moni-Trol® H is intended for use<br>as a consistent test sample of<br>known concentration for |
| | | |
| Description of<br>device | monitoring assay conditions in<br>many clinical laboratory<br>determinations. Include Moni-<br>Trol® H with patient serum<br>specimens when assaying for<br>any of the listed constituents.<br>The user can compare<br>observations with expected<br>ranges as a means of assuring<br>consistent performance of<br>reagent and instrument. | monitoring assay conditions in<br>many clinical laboratory<br>determinations. Include Moni-<br>Trol® H with patient serum<br>specimens when assaying for<br>any of the listed constituents.<br>The user can compare<br>observations with expected<br>ranges as a means of assuring<br>consistent performance of<br>reagent and instrument. |
| Matrix | This product is a liquid stable<br>control material prepared from<br>human serum. | This product is a liquid stable<br>control material prepared from<br>human serum. |
| Storage<br>Condition | -20°C | -20°C |

### Comparison of Technological Characteristics

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:

| Analyte<br>List | Predicate Device<br>K030942 | Modified Device<br>Proposed Analytes<br>(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,<br>HBDH* | Hydroxybutyrate Dehydrogenase,<br>HBDH* |
| | High Density Lipoprotein | High Density Lipoprotein |
| | Cholesterol, HDL | Cholesterol, HDL |
| | Human Chorionic Gonadotrophin,<br>hCG | Human Chorionic Gonadotrophin,<br>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 |
| Analyte<br>List,<br>Cont. | Lipase | Lipase<br>Lipoprotein (LpA)* |
| | Lithium | Lithium |
| | Low Density Lipoprotein<br>Cholesterol, 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<br>(UIBC) | Unsaturated Iron Binding Capacity<br>(UIBC)* |

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and the comments of the comments of the comments of

1999 - 1999 - 1999

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:

.

:

.

:

.

,

:

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 [phone]. 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 [phone]. 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 [phone] 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:

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 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

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