# K031856: Preciset TDM I and Preciset TDM II Calibrators

- Pathway: 510(k) (Abbreviated)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 6, 2003 after 51 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K842280 (1984). 21 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851032: Cobas FP Reagents for Digoxin & Cobas FP Digoxin C, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K850807: Cobas FP Reagents for Carbamazepine, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K843827: Cobas Reagents for Gentamicin & Calibrat, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K945523: Cobas (R)-FP Reagents for Gentamicin and Cobas (R)-FP Gentamicin Calibrators, Roche Diagnostic Systems, Inc. (1995) Summary page 1.
- K936131: Cobas-FP Reagent for Phenytoin and Coba-FP Phenytoin Calibrators, Roche Diagnostic Systems, Inc. (1994) Summary page 1.
- K936130: Cobas-FP Reagent for Phenobarbital and Cobas-FP Phenobarbital Calibrators, Roche Diagnostic Systems, Inc. (1994) Summary page 1.
- K852318: Cobas FP Reagen for Primidone & Primi Calibrators, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K871484: Cobas FP Reagents for Theophylline & Calibrators, Roche Diagnostic Systems, Inc. (1987) Summary page 1.
- K843828: Cobas Reagents for Tobramycin & Calibra, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K925003: Cobas-FP Reagent for Valproic Acid and Calibrators, Roche Diagnostic Systems, Inc. (1992) Summary page 1.
- K901759: Cobas-FP Reagents for Vancomycin, Roche Diagnostic Systems, Inc. (1990) Summary page 1.
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents, Roche Diagnostic Systems, Inc. (1997) Summary page 1.
- K852317: Cobas FP Reagen for Amikacin & Amikacin Calibrator, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K853010: Cobas Reagent for Lidocaine & Calibrators, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K871680: Modified Cobas FP Reagents for Napa and Calibrator, Roche Diagnostic Systems, Inc. (1987) Summary page 1.
- K852320: Cobas FP Reagen for Procainamide & Pro Calibrator, Roche Diagnostic Systems, Inc. (1985) Summary page 1.
- K942847: Cobas (R)-FP Reagent for Procainamide/Calibrator, Roche Diagnostic Systems, Inc. (1994) Summary page 1.
- K941440: Cobas-FP Quinidine Reagents and Calibrators, Roche Diagnostic Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K091617: QMS Lidocaine Calibrators, Model 0374678 (2009), 0 descendants of its own

## Recalls of this device
- Apr 22, 2009 · Not classified · Z-2001-2009: The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.
- Apr 22, 2009 · Not classified · Z-2000-2009: The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles.

## 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.

Source page: https://510kreport.com/device/K031856
Methodology: https://510kreport.com/methodology