(51 days)
Not Found
No
The device description focuses on the chemical composition and preparation of calibrators for automated clinical chemistry analyzers. There is no mention of AI or ML in the intended use, device description, or any other section of the summary.
No
This device is a calibrator used for the quantitative determination of certain drugs in human serum and plasma, which assists in monitoring drug levels, but it does not directly provide therapy.
No.
This device is a set of calibrators used to calibrate other Roche assays for the quantitative determination of various drugs in human serum and plasma. It does not directly perform diagnostic measurements or interpret results.
No
The device description clearly states that the calibrators contain physical substances (drugs in human serum with stabilizer and preservative) in bottles, which are hardware components.
Based on the provided information, the Roche Preciset TDM I and Preciset TDM II calibrators are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use explicitly states they are "designed for the calibration of the Roche assays for the quantitative determination of [various drugs] in human serum and plasma on automated clinical chemistry analyzers." This clearly indicates they are used in vitro (outside the body) to calibrate instruments that perform diagnostic tests on human samples.
- Device Description: The description details the composition of the calibrators (drugs in human serum) and how they are used in a set with different levels, which is typical for calibrators used in diagnostic testing.
- Predicate Devices: The listed predicate devices are also calibrators for therapeutic drug monitoring (TDM) assays, which are a type of in vitro diagnostic test.
Therefore, the function and intended use of these calibrators align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Preciset TDM I calibrators are designed for the calibration of the Roche assays for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, phenobarbital, primidone, theophylline, tobramycin, valproic acid and vancomycin in human serum and plasma on automated clinical chemistry analyzers.
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.
Product codes (comma separated list FDA assigned to the subject device)
DKB
Device Description
Roche Preciset TDM I calibrators contain a mixture of 10 different drugs, prepared by the quantitative addition of drug to human serum, with the addition of a stabilizer and preservative. The calibrator set contains six levels for each drug contained in bottles A-F. Bottle A is negative (drug free) human serum, followed by bottles B-F containing increasing amounts of each drug in a multi-analyte mixture. A single bottle containing 10 ml of drug-free human serum is also provided as a diluent.
Roche Preciset TDM II calibrators contain a mixture of 6 different drugs, prepared by the quantitative addition of drug to human serum, with the addition of a stabilizer and preservative. Drugs included are Digitoxin, Amikacin, Lidocaine, NAPA, Procainamide, and Quinidine. This calibrator set also provides six levels for each drug contained in bottles A-F. Bottle A is negative (drug free) human serum, followed by bottles B-F containing increasing amounts of each drug in a multi-analyte mixture. A single bottle containing 10 ml of drug-free human serum is also provided as a diluent.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K851032, K850807, K843827, K945523, K936131, K936130, K852318, K871484, K843828, K925003, K901759, K972250, K852317, K853010, K871680, K852320, K942847/S2
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
AUG = 6 2003
| 510(k) Summary | AUG - 6 2003
K031856 |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
| 1) Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 521-7637
Contact Person: Kerwin Kaufman
Date Prepared: June 13, 2003 |
| 2) Device name | Proprietary name: Preciset TDM I and Preciset TDM II Calibrators
Common name: Calibrators, Drug Mixture
Classification name: Clinical Toxicology Calibrator |
| 3) Predicate
devices | We claim substantial equivalence to the currently marketed Roche calibrators:
Cobas-FP Digoxin Calibrators, K851032
Cobas-FP Carbamazepine Calibrators, K850807
Cobas-FP Gentamicin Calibrators, K843827 and K945523
Cobas-FP Phenytoin Calibrators, K936131
Cobas-FP Phenobarbital Calibrators, K936130
Cobas-FP Primidone Calibrators, K852318
Cobas-FP Theophylline Calibrators, K871484
Cobas-FP Tobramycin Calibrators, K843828
Cobas-FP Valproic Acid Calibrators, K925003
Cobas-FP Vancomycin Calibrators, K901759
Roche TDM ONLINE Digitoxin Calibrators, K972250
Cobas-FP Amikacin Calibrators, K852317
Cobas-FP Lidocaine Calibrators, K853010
Cobas-FP NAPA Calibrators, K871680
Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 |
1
510(k) Summary, Continued
Roche Preciset TDM I calibrators contain a mixture of 10 different drugs, 4) Device prepared by the quantitative addition of drug to human serum, with the Description addition of a stabilizer and preservative. The calibrator set contains six levels for each drug contained in bottles A-F. Bottle A is negative (drug free) human serum, followed by bottles B-F containing increasing amounts of each drug in a multi-analyte mixture. A single bottle containing 10 ml of drug-free human serum is also provided as a diluent. Drugs and their respective levels included are as follows:
Digoxin: 0, 0.5, 1, 2, 3, 5 ng/ml Carbamazepine: 0, 1.25, 2.5, 5, 10, 20 µg/ml Gentamicin: 0, 0.5, 1.5, 4, 7, 10 µg/ml Phenytoin: 0, 2.5, 5, 10, 20, 40 µg/ml Phenobarbital: 0. 5, 10, 20, 40, 60 µg/ml Primidone: 0, 2, 4, 8, 16, 24 µg/ml Theophylline: 0, 2.5, 5, 10, 20, 40 µg/ml Tobramycin: 0, 1, 2, 4, 7, 10 µg/ml Valproic Acid: 0, 12.5, 25, 50, 100, 150 µg/ml Vancomycin: 0, 5, 10, 20, 40, 80 µg/ml
Roche Preciset TDM II calibrators contain a mixture of 6 different drugs, prepared by the quantitative addition of drug to human serum, with the addition of a stabilizer and preservative. Drugs included are Digitoxin, Amikacin, Lidocaine, NAPA, Procainamide, and Quinidine. This calibrator set also provides six levels for each drug contained in bottles A-F. Bottle A is negative (drug free) human serum, followed by bottles B-F containing increasing amounts of each drug in a multi-analyte mixture. A single bottle containing 10 ml of drug-free human serum is also provided as a diluent. Drugs and their respective levels included are as follows:
Digitoxin: 0, 7.5, 15, 30, 45, 65 ng/ml Amikacin: 0, 2.5, 5, 10, 20, 40 µg/ml Lidocaine: 0, 0.5, 1, 2.5, 5, 10 ug/ml NAPA: 0, 2.5, 5, 10, 20, 30 µg/ml Procainamide: 0, 1, 2, 4, 8, 16 ug/ml Quinidine: 0, 0.5, 1, 2, 4, 8 µg/ml
Continued on next page
2
510(k) Summary, Continued
| 5.) Intended
Use | The Preciset TDM I calibrators are designed for the calibration of the Roche assays for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, phenobarbital, primidone, theophylline, tobramycin, valproic acid and vancomycin in human serum and plasma on automated clinical chemistry analyzers.
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. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.) Comparison
to the Predicate
Device | The Roche Preciset TDM I and Preciset TDM II multianalyte calibrators are substantially equivalent to other products in commercial distribution intended for similar use. Most notably, they are substantially equivalent to the currently marketed Roche single analyte TDM calibrators (listed in section 3 above) for the same drugs and at the same levels.
The Roche Preciset TDM I and Preciset TDM II multianalyte calibrators are prepared by the quantitative addition of drugs to human serum with an added stabilizer and preservative. Drugs are added in the same quantities as the predicate, single analyte TDM calibrators. The new multianalyte calibrators provide a more convenient calibrator set for multiple TDM assays than the predicate, single analyte TDM calibrator sets. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines, possibly representing movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
AUG - 6 2003
Re: K031856
Trade/Device Name: Roche Preciset TDM I and Preciset TDM II Calibrators Regulation Number: 21 CFR § 862.3200 Regulation Name: Clinical toxicology calibrator Regulatory Class: II Product Code: DKB Dated: June 13, 2003 Received: June 16, 2003
Dear Mr. Kaufman:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
iteven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
.
| 510(k) Number (if known): | K031856 |
|---|---|
| Device Name: | Roche Preciset TDM I and Preciset TDM II Calibrators |
| Indications for Use: | The Preciset TDM I calibrators are designed for the calibration of the Roche assays for the quantitative determination of digoxin, carbamazepine, gentamicin, phenytoin, phenobarbital, primidone, theophylline, tobramycin, valproic acid and vancomycin in human serum and plasma on automated clinical chemistry analyzers. |
| 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-the-Counter Use
(Per 21 CFR 801.109)
(Optional format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Devic Evaluation and Safety
| 510(k) | K031856 |
|---|---|
| -------- | --------- |