(44 days)
Not Found
No
The document describes a set of calibrators for a laboratory assay, which are chemical reagents used for calibration, not a device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
This device is a calibrator set used to calibrate an assay, not for treating patients.
No
Explanation: The device is a calibrator set used to calibrate an assay, not to diagnose a condition itself.
No
The device is described as a "calibrator set" with specific concentrations of lidocaine, indicating it is a physical substance used for calibration, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "calibration of the QMS Lidocaine assay." Calibration is a crucial step in ensuring the accuracy of an in vitro diagnostic test (the QMS Lidocaine assay).
- Device Description: It's a set of calibrators containing a specific analyte (lidocaine) at known concentrations. Calibrators are essential components used in many IVD tests to establish a standard curve for quantitative measurements.
- Predicate Device: The mention of a predicate device (Roche Preciset TDM II Calibrators) which is also a set of calibrators for therapeutic drug monitoring (TDM) further supports its classification as an IVD. TDM assays are a type of in vitro diagnostic test.
While the document doesn't contain all the information typically found in an IVD submission (like performance data, patient age range, etc.), the core function and intended use clearly place it within the realm of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.
Product codes
DLJ
Device Description
The QMS Lidocaine Calibrator set is a six-level set (0, 0.5, 1.0, 10 µg/mL) of single analyte (lidocaine) calibrators.
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
Not Found
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
Not Found
Key Metrics
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
K09/617
JUL 1 7 2009
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:
COMPANY/CONTACT PERSON
Thermo Fisher Scientific Inc Seradyn, Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Establishment registration No: 1836010
Jack Rogers Sr. Manager of Regulatory Affairs Telephone: (317) 610-3823 Fax: (317) 610-0018
DATE PREPARED
June 2, 2009
DEVICE NAME
| Trade Name: | QMS ® Lidocaine Calibrators |
|---|---|
| Common Name: | Calibrators, Drug Specific |
| Device Classification: | 21 CFR 862.3200; Clinical Toxicology Calibrator; Class II |
INTENDED USE
The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.
LEGALLY MARKETED DEVICE TO WHICH EQUIVALENCY IS CLAIMED
Roche Preciset TDM II Calibrators K031856
DESCRIPTION OF DEVICE
The QMS Lidocaine Calibrator set is a six-level set (0, 0.5, 1.0, 10 µg/mL) of single analyte (lidocaine) calibrators.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The QMS Lidocaine Calibrators are prepared by quantitative addition of lidocaine to human serum, with an added preservative. Lidocaine is added in the same quantities as the predicate, multi-analyte calibrators, in order to achieve a 6-level set of calibrators.
| | Device
QMS Lidocaine Calibrators | Predicate
Roche Preciset TDM II Calibrators |
|--------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The QMS Lidocaine Calibrator set is
intended for use in calibration of the QMS
Lidocaine assay. | The Preciset TDM II Calibrators are
designed for the calibration of the
Roche assays for the quantitative
determination of digitoxin, amikacin,
lidocaine, N-acetylprocainamide,
procainamide and quinidine in human
serum and plasma on automated
clinical chemistry analyzers. |
| Components | 6-level set of calibrators each
containing lidocaine at the following
concentrations: | Mixture of 6 different drugs, including
lidocaine at the following
concentrations: |
| | 0, 0.5, 1.0, 2.5, 5.0, 10 µg/mL | 0, 0.5, 1.0, 2.5, 5.0, 10 µg/mL |
| Matrix | Human serum | Human serum |
CONCLUSION
As summarized above, the QMS Lidocaine Calibrators are substantially equivalent to the Roche Preciset TDM II Calibrators. Substantial equivalence has been demonstration io the notify in the notify that the device functions as intended and that design specifications have been satisfied.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes that are stacked vertically. The symbol is black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Thermo Fisher Scientific c/o Mr. Jack Roger Manager Regulatory Affairs Seradyn. Inc 7998 Georgetown Road, Suite 1000 Indianapolis, IN 46268
Re:
JUL 1 7 2009
K091617 Trade Name: QMS Lidocaine Calibrators Regulation Number: 21 CFR §862.1150 Regulation Name: Calibrators Regulatory Class: Class II Product Codes: DLJ Dated: June 02, 2009 Received: June 03, 2009
Dear Mr. Roger:
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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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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Indications for Use
510(k) Number (if known): K091617
Device Name:
QMS® Lidocaine Calibrators
Indications for Use:
. The QMS Lidocaine Calibrator set is intended for use in calibration of the QMS Lidocaine assay.
Prescription Use × (Part 21 CFR 801 Subpart D)
And/Or
Over-The-Counter Use (21 CFR 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)
Diyision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
K091617 510(k) _
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