(290 days)
Not Found
No
The summary describes calibrators for drug assays, which are chemical reagents used for calibration and quality control. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a calibrator used for in vitro diagnostic assays to detect drugs in oral fluid, which is a laboratory tool and not used for direct treatment or diagnosis of a disease or condition in a patient.
No
This device is described as a calibrator for in vitro diagnostic assays, not a diagnostic device itself. It is used to calibrate other diagnostic devices (the CEDIA Amphetamine, Cocaine, Opiate, and Phencyclidine (PCP) OFT Assays).
No
The device is a liquid calibrator, which is a physical substance used in laboratory testing, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "This in vitro diagnostic device is intended for clinical laboratory use only." This is a direct declaration of its IVD status.
- The intended use describes its function in calibrating assays for detecting drugs in human oral fluid, which is a biological sample tested in vitro (outside the body).
N/A
Intended Use / Indications for Use
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.
Product codes
DKB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence has been demonstrated through performance testing to verify that the device functions as intended and that design specifications have been satisfied.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
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
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.
1
| 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 Device
CEDIA® Multi-Drug OFT
Calibrators | Predicate Device
CEDIA Multi-Drug DAU
Calibrators (K980853) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | The CEDIA® DAU Multi-Drug
Calibrators are intended for the
calibration of qualitative and semi
quantitative CEDIA® DAU Assays on
automated clinical chemistry
analyzers. |
| Analytes | Amphetamine
Benzoylecgonine
Morphine
Phencyclidine (PCP) | Benzoylecgonine
EDDP
d-Methamphetamine
Morphine
Nitrazepam
Phencyclidine (PCP)
Secobarbital |
| Matrix | Buffer | Urine |
| Form | Liquid, ready to use | Liquid, ready to use |
| Calibrator
levels | Negative
Cutoff
High | Primary Cutoff
Secondary Cutoff
Intermediate Calibrator
High Calibrator |
| Storage
Temperature | 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.
2
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).
3
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
4
Indication for Use
510(k) Number (if known): K101752
Device Name: Thermo Scientific CEDIA® Multi-Drug OFT Calibrators
Indication for Use:
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.
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