ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS

K120936 · Microgenics Corporation · DKB · Dec 13, 2012 · Clinical Toxicology

Device Facts

• Record ID: K120936
• Device Name: ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS
• Applicant: Microgenics Corporation
• Product Code: DKB · Clinical Toxicology
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended 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 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 Story

TDM Multiconstituent Calibrator set consists of 6 levels of liquid, ready-to-use calibrators prepared from a bovine serum matrix; contains analytes amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, valproic acid, and vancomycin. Preserved with sodium azide and ProClin 300. Used in clinical laboratories to calibrate automated analyzers (e.g., ARCHITECT cSystems) for therapeutic drug monitoring. Healthcare providers use the resulting assay calibration to quantify drug concentrations in patient serum/plasma samples. Accurate calibration ensures reliable drug level measurements, supporting clinical decisions regarding dosage adjustments and toxicity monitoring, ultimately benefiting patients by maintaining therapeutic drug ranges.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via accelerated and real-time studies (24-month shelf life at 2-8°C; 60-day open-bottle stability). Traceability established to USP reference standards via gravimetric addition to human serum pools.

Technological Characteristics

Bovine serum matrix; liquid, ready-to-use form. Contains analytes: amikacin, carbamazepine, digoxin, gentamicin, phenytoin, quinidine, theophylline, valproic acid, vancomycin. Preservatives: 0.09% sodium azide, 0.1% ProClin 300. Storage: 2-8°C. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic calibration of therapeutic drug monitoring assays (Amikacin, Carbamazepine, Digoxin, Gentamicin, Phenobarbital, Phenytoin, Quinidine, Theophylline, Valproic Acid, Vancomycin) in human serum and plasma on clinical laboratory analyzers.

Regulatory Classification

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.)

Special Controls

*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.

Predicate Devices

• CEDIA TDM Core Multi-cals (k961659)

Submission Summary (Full Text)

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## 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: [phone] x31814 [phone] Fax: E-mail: [e-mail]

## Date Prepared

March 23, 2012

#### Regulatory Declarations

| Common / Usual Name | TDM Multiconstituent Calibrator<br>QMS® TDM Multi-Constituent Calibrator |
|---------------------------|---------------------------------------------------------------------------------------------------|
| Trade / Proprietary Name | Abbott TDM Multiconstituent Calibrator<br>Thermo 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

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.

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### QMS® Multi-Constituent 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.

#### 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

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.

| 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.

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| 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.

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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.

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## Summary of Testing

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| Evaluation Parameter | Design Input | Acceptance Criteria | Pass / Fail |
|----------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Target Achievement | The concentration of<br>pilots meet design input<br>targets | L1: Negative<br>L2: Difference within<br>+/-0.3 µg/mL<br>(Amikacin)<br>+/-0.5 µg/mL<br>(Carbamazepine)<br>+/-0.1 ng/mL<br>(Digoxin)<br>+/-0.1 µg/mL<br>(Gentamicin)<br>+/-1.0 µg/mL<br>(Phenobarbital)<br>+/-0.6 µg/mL<br>(Phenytoin)<br>+/-0.2 µg/mL<br>(Quinidine)<br>+/-0.6 µg/mL<br>(Theophylline)<br>+/-3.0 µg/mL<br>(Valproic Acid)<br>+/-0.5 µg/mL<br>(Vancomycin)<br>L3: Difference within<br>+/-15% (Digoxin)<br>+/-10% (all other<br>analytes)<br>L4 to L6: Difference<br>within+/- 10%<br>(All analytes) | Pass |
| Antimicrobial<br>Effectiveness Test (USP<br>Category 4) | Result be "NI" per<br>Pacifica BioLabs SOP<br>#13B-10, Rev. 7D00 | Pass challenge against:<br><i>P. aeruginosa</i><br><i>E. coli</i><br><i>S. aureus</i><br><i>C. albicans</i><br><i>A. niger</i> | Pass |
| Open Bottle Stability | 60 days @2-8°C | L1: Negative<br>L2 to L6: Value change<br>within +/-10% | Pass |
| Accelerated Stress<br>Stability to Predict Shelf<br>Life | >=12 months @2-8°C | L1: Negative<br>L2 to L6: Value change<br>within +/-10% | Predicted<br>(24 months @2-8°C) |
| Real-Time Stability | >=12 months @2-8°C | L1: Negative<br>L2: Value change within<br>+/-15%<br>L3 to L6: Value change<br>within +/-10% | In process |

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| Comparison | Proposed Device | Predicate 1 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary Name | TDM Multiconstituent Calibrator | CEDIA TDM Core Multi-Cals |
| Intended Use | For in vitro diagnostic use in the calibration<br>of the Amikacin, Carbamazepine, Digoxin,<br>Gentamicin, Phenobarbital, Phenytoin,<br>Quinidine, Theophylline, Valproic Acid, and<br>Vancomycin human serum and plasma<br>assays on the ARCHITECT cSystems.<br>Lot-specific calibrator for the ARCHITECT<br>cSystems are listed in the TDM MCC Value<br>Sheet, packaged with the calibrator. | The CEDIA Core TDM Multi-Cals are used to<br>calibrate the CEDIA assays for<br>carbamazepine, phenobarbital, phenytoin,<br>theophylline, and valproic acid in human<br>serum and plasma. |
| Analytes | Amikacin<br>Carbamazepine<br>Digoxin<br>Gentamicin<br>Phenobarbital<br>Phenytoin<br>Quinidine<br>Theophylline<br>Valproic Acid<br>Vancomycin | Carbamazepine<br>Phenobarbital<br>Phenytoin<br>Theophylline<br>Valproic 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.

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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

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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 [phone]. 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 [phone]. 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 [phone] 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

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# 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

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.

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

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