For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin human serum and plasma assays on the ARCHITECT cSystems. Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator.

For in vitro diagnostic use in the calibration of assays for the detection of Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, and Vancomycin in human serum and plasma for use on clinical laboratory analyzers. Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged with the calibrator.

Device Description

Each TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set is packaged in a rectangular cardboard box with a 12-bottle divider, a product insert, and a value sheet. Kits are stored refrigerated at 2-8°C. Each kit contains 6 levels of calibrators with the following configurations. The TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set are prepared from a bovine serum matrix and contains the following analytes: amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, theophylline, valproic acid, and vancomycin. Sodium azide at 0.09% and ProClin 300 at 0.1% are present as preservatives. TDM Multiconstituent Calibrator and QMS® TDM Multi-Constituent Calibrator levels are provided in liquid ready to use form and to be stored at 2-8°C until the expiration date on the label. Once opened, the opened bottles are stable for 60 days when capped tightly and stored at 2-8°C.

AI/ML Overview

The provided 510(k) summary describes a calibrator device for in vitro diagnostic use, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, ground truth for training set) are not applicable to this document.

However, I can extract the acceptance criteria and reported device performance from the provided "Summary of Testing" table.

Acceptance Criteria and Reported Device Performance

Evaluation Parameter	Acceptance Criteria	Reported Device Performance
Target Achievement	L1: NegativeL2: Difference within +/- 0.3 µg/mL (Amikacin), +/- 0.5 µg/mL (Carbamazepine), +/- 0.1 ng/mL (Digoxin), +/- 0.1 µg/mL (Gentamicin), +/- 1.0 µg/mL (Phenobarbital), +/- 0.6 µg/mL (Phenytoin), +/- 0.2 µg/mL (Quinidine), +/- 0.6 µg/mL (Theophylline), +/- 3.0 µg/mL (Valproic Acid), +/- 0.5 µg/mL (Vancomycin)L3: Difference within +/- 15% (Digoxin), +/- 10% (all other analytes)L4 to L6: Difference within +/- 10% (All analytes)	Pass
Antimicrobial Effectiveness Test (USP Category 4)	Pass challenge against: P. aeruginosa, E. coli, S. aureus, C. albicans, A. niger	Pass
Open Bottle Stability	L1: NegativeL2 to L6: Value change within +/- 10%	Pass
Accelerated Stress Stability to Predict Shelf Life	L1: NegativeL2 to L6: Value change within +/- 10%	Predicted (24 months @2-8°C)
Real-Time Stability	L1: NegativeL2: Value change within +/- 15%L3 to L6: Value change within +/- 10%	In process

Non-Applicable / Not Provided Information for AI/ML Device Study:

The following information is either not applicable to this type of medical device (a calibrator for IVD assays) or is not provided in the summary document:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a calibrator. The testing involves laboratory measurements of the calibrator's performance against defined targets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" for a calibrator would refer to the true concentrations of the analytes, which are established during its manufacturing and characterization rather than by expert review of patient data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is an IVD calibrator, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" implicitly refers to the accurately assigned target concentrations of the analytes within the calibrator solutions. These are determined through precise chemical analysis and manufacturing processes, not clinical expert consensus or pathology.
The sample size for the training set: Not applicable. There is no AI/ML model to train.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

510(k) 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: K120936

Company / Contact Person

Karen Lee Regulatory Affairs Specialist Thermo Fisher Scientific. Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 Phone: (510) 979-5000 x31814 (510) 979-5422 Fax: E-mail: karen.lee@thermofisher.com

Date Prepared

March 23, 2012

Regulatory Declarations

Common / Usual Name	TDM Multiconstituent CalibratorQMS® TDM Multi-Constituent Calibrator
Trade / Proprietary Name	Abbott TDM Multiconstituent CalibratorThermo Scientific QMS® TDM Multi-Constituent Calibrator
Classification Regulation	21 CFR 862.3200
Device Class	Class II
Device Regulation Panel	Toxicology
Product Code	DKB

Intended Use

TDM Multiconstituent Calibrator

Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator.

{1}------------------------------------------------

QMS® Multi-Constituent Calibrator

Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged with the calibrator.

Legally Marketed Device to Which Equivalency is Claimed

The TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set are substantially equivalent to the previously cleared CEDIA TDM Core Multi-Cals (K961659).

Device Description

Description	Size
Level 1	2 x 5 mL
Level 2	1 x 5 mL
Level 3	1 x 5 mL
Level 4	1 x 5 mL
Level 5	1 x 5 mL
Level 6	1 x 5 mL

Each kit contains 6 levels of calibrators with the following configurations.

The TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set are prepared from a bovine serum matrix and contains the following analytes: amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, theophylline, valproic acid, and vancomycin. Sodium azide at 0.09% and ProClin 300 at 0.1% are present as preservatives.

{2}------------------------------------------------

Analyte	Target						Unit
	L1	L2	L3	L4	L5	L6
Amikacin	0.0	3.0	10.0	20.0	35.0	50.0	µg/mL
Carbamazepine	0.0	2.0	4.0	8.0	12.0	20.0	µg/mL
Digoxin	0.0	0.5	1.0	2.0	3.0	5.0	µg/mL
Gentamicin	0.0	0.5	1.5	3.0	6.0	10.0	µg/mL
Phenobarbital	0.0	5.0	10.0	20.0	40.0	80.0	µg/mL
Phenytoin	0.0	2.5	5.0	10.0	20.0	40.0	µg/mL
Quinidine	0.0	0.5	1.0	2.0	4.0	8.0	µg/mL
Theophylline	0.0	2.5	5.0	10.0	20.0	40.0	µg/mL
Valproic Acid	0.0	12.5	25.0	50.0	100.0	150.0	µg/mL
Vancomycin	0.0	5.0	10.0	25.0	50.0	100.0	µg/mL

· The analytes and targets are listed below.

TDM Multiconstituent Calibrator and QMS® TDM Multi-Constituent Calibrator levels are provided in liquid ready to use form and to be stored at 2-8°C until the expiration date on the label. Once opened, the opened bottles are stable for 60 days when capped tightly and stored at 2-8°C.

{3}------------------------------------------------

Summary of Testing

Evaluation Parameter	Design Input	Acceptance Criteria	Pass / Fail
Target Achievement	The concentration ofpilots meet design inputtargets	L1: NegativeL2: Difference within+/-0.3 µg/mL(Amikacin)+/-0.5 µg/mL(Carbamazepine)+/-0.1 ng/mL(Digoxin)+/-0.1 µg/mL(Gentamicin)+/-1.0 µg/mL(Phenobarbital)+/-0.6 µg/mL(Phenytoin)+/-0.2 µg/mL(Quinidine)+/-0.6 µg/mL(Theophylline)+/-3.0 µg/mL(Valproic Acid)+/-0.5 µg/mL(Vancomycin)L3: Difference within+/-15% (Digoxin)+/-10% (all otheranalytes)L4 to L6: Differencewithin+/- 10%(All analytes)	Pass
AntimicrobialEffectiveness Test (USPCategory 4)	Result be "NI" perPacifica BioLabs SOP#13B-10, Rev. 7D00	Pass challenge against:P. aeruginosaE. coliS. aureusC. albicansA. niger	Pass
Open Bottle Stability	60 days @2-8°C	L1: NegativeL2 to L6: Value changewithin +/-10%	Pass
Accelerated StressStability to Predict ShelfLife	>=12 months @2-8°C	L1: NegativeL2 to L6: Value changewithin +/-10%	Predicted(24 months @2-8°C)
Real-Time Stability	>=12 months @2-8°C	L1: NegativeL2: Value change within+/-15%L3 to L6: Value changewithin +/-10%	In process

: ·

: #

{4}------------------------------------------------

Comparison	Proposed Device	Predicate 1
Proprietary Name	TDM Multiconstituent Calibrator	CEDIA TDM Core Multi-Cals
Intended Use	For in vitro diagnostic use in the calibrationof the Amikacin, Carbamazepine, Digoxin,Gentamicin, Phenobarbital, Phenytoin,Quinidine, Theophylline, Valproic Acid, andVancomycin human serum and plasmaassays on the ARCHITECT cSystems.Lot-specific calibrator for the ARCHITECTcSystems are listed in the TDM MCC ValueSheet, packaged with the calibrator.	The CEDIA Core TDM Multi-Cals are used tocalibrate the CEDIA assays forcarbamazepine, phenobarbital, phenytoin,theophylline, and valproic acid in humanserum and plasma.
Analytes	AmikacinCarbamazepineDigoxinGentamicinPhenobarbitalPhenytoinQuinidineTheophyllineValproic AcidVancomycin	CarbamazepinePhenobarbitalPhenytoinTheophyllineValproic Acid
510k Number	TBD	K961659
Current Manufacturer	Microgenics	Microgenics
Classification Regulation	862.3200	862.1150
Device Class	II	II
Device Regulation Panel	Toxicology	Toxicology
Product Code(s)	DKB	JIX

Comparison of Technological Characteristics

Conclusion

Substantial equivalence of the TDM Multiconstituent Calibrator set and QMS® TDM Multi-Constituent Calibrator set to the previously cleared CEDIA TDM Core Multi-Cals (K961659) has been demonstrated through performance testing (Section 18) to verify that the device functions as intended and design specifications have been satisfied.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 13, 2012

Microgenics Corporation Thermo Fisher Scientific Clinical Diagnostics Division c/o Karen Lee 46360 Fremont Blvd. Fremont, CA 94538

K120936 Re:

Trade Name: Abbott TDM Multiconstituent Calibrator; Thermo Scientific QMS® TDM Multi-Constituent Calibrator Regulation Number: 21 CFR §862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: Class II Product Codes: DKB Dated: November 30, 2012 Received: December 4, 2012

Dear Ms. Lee:

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

{6}------------------------------------------------

Page 2 - Karen Lee

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Carol C. Benson for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use Statement

510(k) Number (if known)

K120936

Device Name

Abbott TDM Multiconstituent Calibrator Thermo Scientific QMS® Multi-Constituent Calibrator

Indications For Use

Abbott TDM Multiconstituent Calibrator

For in vitro diagnostic use in the calibration of the Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Valproic Acid, and Vancomycin human serum and plasma assays on the ARCHITECT cSystems.

Lot-specific calibrator for the ARCHITECT cSystems are listed in the TDM MCC Value Sheet, packaged with the calibrator.

Thermo Scientific QMS® Multi-Constituent Calibrator

Lot-specific calibrator values with specific analyzers are provided in the value sheet packaged with the calibrator.

Prescription Use

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 Diagnostics and Radiological Health (OIR)

AND/OR

. Louise Phoenix-Taylor

Division Sign/Off

Office of In Vitro Diagnostics and Radiological Health

510(k) K120936

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.