The provided text describes a 510(k) premarket notification for the QMS Lidocaine Calibrators. It aims to demonstrate substantial equivalence to a predicate device, the Roche Preciset TDM II Calibrators. However, the document primarily focuses on comparing the intended use, components, and matrix of the new device with the predicate device, rather than presenting a detailed study that proves the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment are not available in the provided text. The document concludes with a claim of substantial equivalence based on the technological characteristics without detailing a performance study with specific acceptance criteria.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated or defined in the provided text. The document aims to demonstrate "substantial equivalence" to a predicate device, implying that its performance attributes should be comparable, but specific numerical acceptance criteria are not provided.
Reported Device Performance: Not explicitly detailed in the provided text. The "Comparison of Technological Characteristics" section compares the design and intended use of the device to the predicate, not a performance evaluation against specific metrics.

2. Sample size used for the test set and the data provenance

Not available. The document does not describe a performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not available. No test set or expert read ground truth is described.

4. Adjudication method for the test set

Not applicable/Not available. No test set or adjudication process is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a calibrator for an assay, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not available. The document focuses on the substance and composition of the calibrator, not on an algorithm's performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not available. In the context of a calibrator, "ground truth" would typically refer to the known, accurate concentration of the analyte (lidocaine) in the calibrator solution. The document states the calibrators are "prepared by quantitative addition of lidocaine to human serum," implying that the concentration values are established by the manufacturing process.

8. The sample size for the training set

Not applicable/Not available. This type of device (a calibrator) does not typically involve a "training set" in the context of machine learning or diagnostic algorithm development.

9. How the ground truth for the training set was established

Not applicable/Not available. As above, no training set is described. The "ground truth" for the calibrator concentrations is established by the precise manufacturing formulation ("quantitative addition of lidocaine to human serum").

Summary

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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.

	DeviceQMS Lidocaine Calibrators	PredicateRoche Preciset TDM II Calibrators
Intended Use	The QMS Lidocaine Calibrator set isintended for use in calibration of the QMSLidocaine assay.	The Preciset TDM II Calibrators aredesigned for the calibration of theRoche assays for the quantitativedetermination of digitoxin, amikacin,lidocaine, N-acetylprocainamide,procainamide and quinidine in humanserum and plasma on automatedclinical chemistry analyzers.
Components	6-level set of calibrators eachcontaining lidocaine at the followingconcentrations:	Mixture of 6 different drugs, includinglidocaine at the followingconcentrations:
	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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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 (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) _

Page 1 of 1

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.