(260 days)
Not Found
No
The document describes a calibrator for in vitro diagnostic assays, which is a chemical reagent used to standardize measurements. There is no mention of any software, algorithms, or data processing that would involve AI or ML.
No.
This device is an in vitro diagnostic calibrator used for laboratory analyzers and is not directly used for treating patients.
Yes
The intended use explicitly states "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". This indicates its role in supporting diagnostic testing.
No
The device description clearly states it is a physical kit containing liquid calibrators in bottles, prepared from a bovine serum matrix with preservatives. This is a hardware product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use in the calibration of..." and "For in vitro diagnostic use in the calibration of assays for the detection of...". This directly aligns with the definition of an IVD, which is a device intended for use in the in vitro examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease.
- Device Description: The device is a calibrator used with clinical laboratory analyzers to measure specific substances (analytes) in human serum and plasma. This is a typical function of an IVD component.
- Summary of Performance Studies: The performance studies described (Target Achievement, Antimicrobial Effectiveness Test, Stability studies) are standard tests performed on IVDs to ensure their quality and reliability for diagnostic purposes.
- Predicate Device(s): The listed predicate device (K961659; CEDIA TDM Core Multi-Cals) is also an IVD, further indicating that this device falls within the IVD category.
Therefore, based on the provided information, this device is clearly intended and used as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DKB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum and plasma
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The summary reports the results of testing concerning:
- Target Achievement: Concentration of pilots meet design input targets. Various difference limits for L1 to L6 depending on the analyte (e.g., L1: Negative, L2: +/-0.3 µg/mL for Amikacin, L4 to L6: +/-10% for all analytes). Result: Pass.
- Antimicrobial Effectiveness Test (USP Category 4): Result be "NI" per Pacifica BioLabs SOP #13B-10, Rev. 7D00. Acceptance Criteria: Pass challenge against: P. aeruginosa, E. coli, S. aureus, C. albicans, A. niger. Result: Pass.
- Open Bottle Stability: 60 days @2-8°C. Acceptance Criteria: L1: Negative, L2 to L6: Value change within +/-10%. Result: Pass.
- Accelerated Stress Stability to Predict Shelf Life: >=12 months @2-8°C. Acceptance Criteria: L1: Negative, L2 to L6: Value change within +/-10%. Result: Predicted (24 months @2-8°C).
- Real-Time Stability: >=12 months @2-8°C. Acceptance Criteria: L1: Negative, L2: Value change within +/-15%, L3 to L6: Value change within +/-10%. Result: In process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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 Calibrator
QMS® TDM Multi-Constituent Calibrator |
|---------------------------|---------------------------------------------------------------------------------------------------|
| Trade / Proprietary Name | Abbott TDM Multiconstituent Calibrator
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.
1
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.
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.
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3
Summary of Testing
.
:
| Evaluation Parameter | Design Input | Acceptance Criteria | Pass / Fail |
|---|---|---|---|
| Target Achievement | The concentration of | ||
| pilots meet design input | |||
| targets | L1: Negative | ||
| L2: 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) | Result be "NI" per | ||
| Pacifica BioLabs SOP | |||
| #13B-10, Rev. 7D00 | Pass challenge against: | ||
| P. aeruginosa | |||
| E. coli | |||
| S. aureus | |||
| C. albicans | |||
| A. niger | Pass | ||
| Open Bottle Stability | 60 days @2-8°C | L1: Negative | |
| L2 to L6: Value change | |||
| within +/-10% | Pass | ||
| Accelerated Stress | |||
| Stability to Predict Shelf | |||
| Life | >=12 months @2-8°C | L1: Negative | |
| L2 to L6: Value change | |||
| within +/-10% | Predicted | ||
| (24 months @2-8°C) | |||
| Real-Time Stability | >=12 months @2-8°C | L1: Negative | |
| L2: Value change within | |||
| +/-15% | |||
| L3 to L6: Value change | |||
| 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 | |
| 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. | The CEDIA Core TDM Multi-Cals are used to | |
| calibrate the CEDIA assays for | ||
| carbamazepine, phenobarbital, phenytoin, | ||
| theophylline, and valproic acid in human | ||
| serum and plasma. | ||
| Analytes | Amikacin | |
| Carbamazepine | ||
| Digoxin | ||
| Gentamicin | ||
| Phenobarbital | ||
| Phenytoin | ||
| Quinidine | ||
| Theophylline | ||
| Valproic Acid | ||
| Vancomycin | Carbamazepine | |
| Phenobarbital | ||
| Phenytoin | ||
| Theophylline | ||
| 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.
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)
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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