(51 days)
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.
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. 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
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Roche Preciset TDM I and Preciset TDM II Calibrators:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific acceptance criteria or report device performance data numerically for the new Preciset TDM I and TDM II calibrators. Instead, the core of the submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.
The document states:
- "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."
- "Drugs are added in the same quantities as the predicate, single analyte TDM calibrators."
Therefore, the implicit acceptance criteria is that the new multi-analyte calibrators perform comparably to the previously approved single-analyte calibrators across all specified drugs and at the same concentration levels. The "reported device performance" is the assertion of being substantially equivalent in formulation and intended use as the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Formulation Equivalence: Multi-analyte calibrators must contain the same drugs at the same quantitative levels as the corresponding predicate single-analyte calibrators. | "Drugs are added in the same quantities as the predicate, single analyte TDM calibrators." |
| Intended Use Equivalence: Multi-analyte calibrators must be designed for calibration of Roche assays for quantitative determination of the specified drugs in human serum and plasma on automated clinical chemistry analyzers, similar to predicate devices. | "The Preciset TDM I calibrators are designed for the calibration of the Roche assays for the quantitative determination of digoxin... etc. in human serum and plasma on automated clinical chemistry analyzers." and "The Preciset TDM II calibrators are designed for the calibration of the Roche assays for the quantitative determination of digitoxin... etc. in human serum and plasma on automated clinical chemistry analyzers." "They are substantially equivalent to the currently marketed Roche single analyte TDM calibrators... for the same drugs and at the same levels." |
| Performance Equivalence: The multi-analyte calibrators must demonstrate equivalent performance to the predicate single-analyte calibrators in terms of their ability to calibrate the associated assays effectively. | "The Roche Preciset TDM I and Preciset TDM II multianalyte calibrators are substantially equivalent to other products in commercial distribution intended for similar use." (This is a claim of overall equivalent performance based on their composition and intended use, rather than specific performance metrics for the new device). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of clinical or performance data collection for the new Preciset TDM I and TDM II calibrators. The submission is based on substantial equivalence, implying that the performance of the new calibrators is extrapolated from the known and accepted performance of the predicate devices, coupled with the identical quantitative drug concentrations.
Therefore:
- Sample size for the test set: Not applicable, as a dedicated performance test set for the new device is not described.
- Data provenance: Not explicitly stated as there is no specific data presented from a new study on the Preciset TDM I and TDM II calibrators. The provenance of the predicate device data would be relevant but is not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As no specific test set data is presented for the new calibrators, there is no mention of experts establishing ground truth for such a set. The ground truth for the predicate devices was implicitly established through their prior FDA clearance and market history.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable, as no specific test set or adjudication process for performance evaluation of the new calibrators is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This is a submission for in-vitro diagnostic calibrators, not an image-based diagnostic device where MRMC studies are common.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a calibrator, an essential component for the proper function of an automated clinical chemistry analyzer to determine drug concentrations. Its performance is intrinsically linked to the analyzer and assays it calibrates, not a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence is the established performance and FDA clearance of the predicate single-analyte TDM calibrators. The new devices are essentially a convenient re-packaging/combination of the same components at the same levels, and their "ground truth" is that they are chemically identical in the relevant aspects to the accepted predicate devices. The ground truth for the predicate devices would likely have involved quantitative analytical methods to confirm drug concentrations and stability, linked to clinical outcomes for appropriate therapeutic drug monitoring.
8. The Sample Size for the Training Set
Not applicable. This device is a pre-manufactured set of calibrators, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device.
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AUG = 6 2003
| 510(k) Summary | AUG - 6 2003K031856 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 521-7637Contact Person: Kerwin KaufmanDate Prepared: June 13, 2003 |
| 2) Device name | Proprietary name: Preciset TDM I and Preciset TDM II CalibratorsCommon name: Calibrators, Drug MixtureClassification name: Clinical Toxicology Calibrator |
| 3) Predicatedevices | We claim substantial equivalence to the currently marketed Roche calibrators:Cobas-FP Digoxin Calibrators, K851032Cobas-FP Carbamazepine Calibrators, K850807Cobas-FP Gentamicin Calibrators, K843827 and K945523Cobas-FP Phenytoin Calibrators, K936131Cobas-FP Phenobarbital Calibrators, K936130Cobas-FP Primidone Calibrators, K852318Cobas-FP Theophylline Calibrators, K871484Cobas-FP Tobramycin Calibrators, K843828Cobas-FP Valproic Acid Calibrators, K925003Cobas-FP Vancomycin Calibrators, K901759Roche TDM ONLINE Digitoxin Calibrators, K972250Cobas-FP Amikacin Calibrators, K852317Cobas-FP Lidocaine Calibrators, K853010Cobas-FP NAPA Calibrators, K871680Cobas-FP Procainamide Calibrators, K852320 and K942847/S2 |
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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
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510(k) Summary, Continued
| 5.) IntendedUse | 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.) Comparisonto the PredicateDevice | 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. |
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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
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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 |
|---|---|
| -------- | --------- |
§ 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.