MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.

MAS® DOA Total provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.

Device Description

DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adjusted with purified drugs or drug metabolites. Preservatives and stabilizers are added to maintain product integrity.

DOA TOTAL offers levels of controls, at concentrations 25% below and 25% above the screening cutoff levels used by the United States Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA); for Amphetamines, PCP (Phencyclidine), Opiates, Cocaine and Marijuana (Cannabinoid).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Thermo Scientific MAS® DOA Total device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Evaluation Parameter	Acceptance Criteria	Reported Device Performance	Pass/Fail
Target Achievement	Analyte concentrations meet specification	L1: Negative; L2-L6: recovery difference vs. target within +/-10%, except LSD which is within +/-15%	Pass
Open Bottle Stability at 5°C	30 days	L1: Negative; L2-L6: recovery change within +/- 10%	Pass
Closed Bottle Stability – Product Shelf Life (5°C)	24 months (predicted)	L1: Negative; L2-L5: recovery change within +/- 15%; L6: recovery change within +/- 20%	Pass

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

The provided document describes control materials (MAS® DOA Total) intended for monitoring assay conditions, not a diagnostic device that processes patient samples to generate a result. Therefore, the concept of a "test set" with patient samples and data provenance (e.g., country of origin, retrospective/prospective) as typically applied to diagnostic algorithms is not directly applicable here.

Instead, the "test set" here refers to the batches of the control material itself that were subjected to various stability and target achievement evaluations. The sample size for these evaluations is not explicitly stated in the provided summary. However, the evaluation parameters imply testing across different levels (L1-L6) and over time for stability studies.

The data provenance is internal to Thermo Fisher Scientific, as they manufactured and tested these control materials.

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

This question is not applicable to this device. MAS® DOA Total is a control material with defined analyte concentrations. The "ground truth" for the control material's composition is established by the manufacturing process and analytical chemistry techniques used to prepare and characterize the material, not by expert interpretation.

4. Adjudication Method for the Test Set

This question is not applicable to this device. As the device is a control material with defined chemical compositions, there is no need for expert adjudication of results. The "truth" is inherent in the manufacturing specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and an AI-powered system might assist or replace them. MAS® DOA Total is a control material, not a diagnostic algorithm or a system that involves human interpretation of patient cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to this device. MAS® DOA Total is a chemical control material, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for MAS® DOA Total is analytical chemistry characterization and manufacturing specifications of the control material itself. The concentrations of the various drugs and metabolites are precisely adjusted and measured during the manufacturing process.

8. The Sample Size for the Training Set

This question is not applicable to this device. MAS® DOA Total is a manufactured control material, not an AI model that requires a training set.

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

This question is not applicable to this device for the same reason as above (not an AI model). The "ground truth" for the control material's composition is established through analytical chemistry and quality control during its production.

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 SMDA 1990 and 21 CFR 807.92

The assigned 510(k) number is: K103656

Company/Contact person

Lisa Charter Manager, Regulatory Affairs Thermo Fisher Scientific, Clinical Diagnostic Division 46360 Fremont Blvd Fremont, CA 94538 Phone: (510) 979-5142 Facsimile: (510) 979-5422 Email: Lisa.Charter@ThermoFisher.com

Date Prepared

February 10, 2011

Requlatory Declarations

Common / Usual Name	MAS® DOA Total
Trade/ Proprietary Name	Thermo Scientific MAS® DOA Total
Classification Regulation	21 CFR 862.3280
Device Class	Class I
Device Regulation Panel	Toxicology
Product Code	DIF

Intended use

MAS® DOA Total provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.

Legally marketed device to which equivalency is claimed

MAS® DOA Total is substantially equivalent to the previously cleared MAS DOA-XSE (K971058) and MGC DAU Control Sets: Primary, Clinical, and Select (K040758).

Description of Device

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Analyte	L2	L3	L4	L5	L6	Concentration
d-Methamphetamine	750	1250	375	625	2000	ng/mL
Secobarbital	225	375	150	250	1000	ng/mL
Nitrazepam	225	375	0	0	0	ng/mL
Oxazepam	0	0	150	250	1000	ng/mL
Buprenorphine	0	0	15	25	60	ng/mL
Benzoylecgonine	225	375	112	118	500	ng/mL
Cotinine	375	625	0	0	0	ng/mL
ETG	375	625	750	1250	0	ng/mL
Ethanol	15	25	40	70	300	mg/dL
LSD	0.3	0.7	0.3	0.7	2.5	ng/mL
Methadone	225	375	225	375	750	ng/mL
EDDP	75	125	750	1250	1500	ng/mL
Methaqualone	225	375	225	375	750	ng/mL
Morphine	225	375	1500	2500	750	ng/mL
Oxycodone	75	125	225	375	750	ng/mL
PCP	19	31	19	31	100	ng/mL
PPX	225	375	225	375	750	ng/mL
Nortriptyline	185	415	750	1250	0	ng/mL
L-A-9-THC-COOH	19	31	38	62	150	ng/mL

Summary of Clinical Testing

EvaluationParameter	AcceptanceCriteria	Specification	Pass /Fail
Target achievement	Analyteconcentrationsmeetspecification	L1: NegativeL2-L6: recovery difference vs.target within +/-10%, except LSDwhich is within +/-15%	Pass
Open Bottle Stabilityat 5°C	30 days	L1: NegativeL2-L6: recovery change within +/- 10%	Pass
Close Bottle Stability– Product Shelf Life(5°C)	24 months(predicted)	L1: NegativeL2-L5: recovery change within +/- 15%L6: recovery change within +/- 20%	Pass

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Conclusion

As summarized, the MAS® DOA Total is substantially equivalent to previously cleared MAS DOA-XSE and MGC DAU Control Sets: Primary, Clinical, and Select. Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.

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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized image of a bird or abstract human figure. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged in a circular fashion around the image. The bird or abstract human figure is located to the right of the text and is composed of three curved lines.

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

Microgenics Corporation Thermo Fisher Scientific, Clinical Diagnostics Division c/o Ms. Lisa Charter Manager, Regulatory Affairs 46360 Fremont Blvd. Fremont, CA 94538-6406

MAR 2 4 2011

Re: K103656

Trade Name: Thermo Scientific MAS R DOA Total Regulation Number: 21 CFR §862.3280 Regulation Name: Clinical toxicology control material. Regulatory Class: Class I, reserved Product Codes: DIF Dated: February 10, 2011 Received: February 14, 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 Acts 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 Parts 801 and 809), 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 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 mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

C.C.

Courtney Harper, 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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Indications for Use

510(k) Number (if known): K103656

Device Name: Thermo Scientific MAS® DOA Total

Indication for Use:

MAS® DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-2-9-THC-COOH.

MAS® DOA Total provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.

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

ARS

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

510(k) K103656

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.