The CEDIA® Multi-Drug OFT Calibrators are intended for use in the calibration of d-Amphetamine, Benzoylecgonine, Morphine and Phencyclidine (PCP) in human Oral Fluid when used with the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidine (PCP) OFT Assays on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.

Device Description

The CEDIA® Multi-Drug OFT Calibrators are liquid ready-to-use. They are prepared by spiking known quantities of Amphetamine, Benzoylecgonine, Morphine and PCP in to buffer matrix. The Cutoff Calibrator is used as a qualitative cutoff reference for distinguishing "positive" from "negative" samples. The concentration for each drug in the calibrators is listed in table below. Concentrations for each calibrator are confirmed by LC-MS/MS methodology.

AI/ML Overview

The provided text describes a 510(k) submission for the CEDIA® Multi-Drug OFT Calibrators, focusing on its substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The document primarily focuses on:

Intended Use: Calibration of specific drugs (d-Amphetamine, Benzoylecgonine, Morphine, Phencyclidine (PCP)) in human Oral Fluid when used with CEDIA OFT Assays on the MGC 240 analyzer.
Device Description: Liquid, ready-to-use calibrators prepared by spiking known quantities of drugs into a buffer matrix. Concentrations are confirmed by LC-MS/MS.
Comparison to Predicate Device: Table outlining similarities and differences in intended use, analytes, matrix, form, calibrator levels, and storage temperature.
Conclusion: Substantial equivalence due to performance testing verifying intended function and satisfaction of design specifications.

Therefore, based on the provided text, I cannot provide answers to the requested information (1-9) as they pertain to performance acceptance criteria and efficacy studies typically found in clinical validation reports for diagnostic devices.

The document states: "Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied." However, it does not provide any details about this "performance testing," including:

Specific acceptance criteria: What quantitative thresholds were set for performance?
Performance results: What were the reported metrics (e.g., accuracy, precision, bias)?
Study design details: Sample size, data provenance, ground truth establishment, expert involvement, etc.

Without this information, it's impossible to fill in the requested table or answer the subsequent questions about the study. This document appears to be just the 510(k) summary and the FDA's clearance letter, not the detailed performance study report itself.

Summary

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APR = 8 2011

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: K101752

Company/Contact person

Lisa Charter Manager, Requlatory 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

May 17, 2010

Regulatory Declarations

Common / Usual Name	CEDIA® Multi-Drug OFT Calibrators
Trade/ Proprietary Name	Thermo CEDIA® Multi-Drug OFT Calibrators
Classification Regulation	21 CFR 862.3200
Device Class	Class II
Device Regulation Panel	Toxicology
Product Code	DKB

Intended use

Legally marketed device to which equivalency is claimed

The CEDIA® Multi-Drug OFT Calibrators are substantially equivalent to the previously cleared CEDIA® DAU Multi-Drug Calibrators (K980853).

Description of the device

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Compound	Cutoff Calibrator(ng/mL)	High Calibrator(ng/mL)
Amphetamine	50	200
Benzoylecgonine	5	50
Morphine	10	80
Phencyclidine	1	20

Comparison of Technological Characteristics to the predicate device

Comparison	Subject DeviceCEDIA® Multi-Drug OFTCalibrators	Predicate DeviceCEDIA Multi-Drug DAUCalibrators (K980853)
Intended Use	The CEDIA® Multi-Drug OFTCalibrators are intended for use inthe calibration of d-Amphetamine,Benzoylecgonine, Morphine andPhencyclidine (PCP) in human OralFluid when used with the CEDIAAmphetamine, Cocaine, Opiate, andPhencyclidine (PCP) OFT Assayson the MGC 240 analyzer. This invitro diagnostic device is intendedfor clinical laboratory use only.	The CEDIA® DAU Multi-DrugCalibrators are intended for thecalibration of qualitative and semiquantitative CEDIA® DAU Assays onautomated clinical chemistryanalyzers.
Analytes	AmphetamineBenzoylecgonineMorphinePhencyclidine (PCP)	BenzoylecgonineEDDPd-MethamphetamineMorphineNitrazepamPhencyclidine (PCP)Secobarbital
Matrix	Buffer	Urine
Form	Liquid, ready to use	Liquid, ready to use
Calibratorlevels	NegativeCutoffHigh	Primary CutoffSecondary CutoffIntermediate CalibratorHigh Calibrator
StorageTemperature	2-8°C	2-8°C

Conclusion

. .

As summarized, the CEDIA® Multi-Drug OFT Calibrators are substantially equivalent to the CEDIA® Multi-Drug DAU Calibrators. 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

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

APR 0 8 2011

Re: K101752

Trade Name: Thermo Scientific CEDIA Multi-Drug OFT Calibrators Regulation Number: 21 CFR §862.3200 Regulation Name: Clinical Toxicology Calibrator Regulatory Class: Class II Product Codes: DKB Dated: March 24, 2011 Received: March 28, 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 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 from mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courmey 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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Indication for Use

510(k) Number (if known): K101752

Device Name: Thermo Scientific CEDIA® Multi-Drug OFT Calibrators

Indication for Use:

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)

Carol C. Benam

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

510(k) K101752

Regulation Number and Section

§ 862.3200 Clinical toxicology calibrator.

(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special 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.