# K033879: Validate TDM Calibration Verification Test Set, Model 126

- Pathway: 510(k) (Traditional)
- Applicant: Maine Standards Co.
- Decided: Feb 27, 2004 after 74 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913309 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913309: TDM I Linearity Test Set, Casco Standards (1991) Summary page 1.
- (no number) Human serum spiked with salicylate: named in the summary without a submission number

## Indications for use
The VALIDATE TDM Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following analytes: acetaminophen, amikacin, carbamazepine, digoxin, gentamicin, lidocaine, N-acetylprocainamide, phenobarbital, phenytoin, primidone, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid, and vancomycin.

Source page: https://510kreport.com/device/K033879
Methodology: https://510kreport.com/methodology