510(k) · Cleared

Cleared

Validate TDM Calibration Verification Test Set, Model 126

K033879510(k) TraditionalCleared Feb 27, 200474-day reviewClass II21 CFR 862.3200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Maine Standards Co. · DKB Calibrators, Drug Mixture

Cleared on Feb 27, 2004 as substantially equivalent to K913309 (Casco Standards, 1991) after a 74-day review. Its family tree reaches back 1 generation to 1991.

Decided: Feb 27, 2004
Review: 74 days
Class: Class II
Product code: DKB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K913309 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK913309 TDM I Linearity Test SetCasco Standards · 1991
This deviceK033879 Validate TDM Calibration Verification Test Set, Model 126Maine Standards Co. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913309	TDM I Linearity Test Set	Casco Standards	1991	—
0 (this device)	K033879	Validate TDM Calibration Verification Test Set, Model 126	Maine Standards Co.	2004	—

FIG. 1 — Lineage of K033879, 1991–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K913309	TDM I Linearity Test Set Summary page 1 …t Set Common Name: Calibration Verification Classification Name: Calibrator, Multi-Analyte Predicate Devices: 1. DOCUMENT TDM I CAL-VER, K913309, manufactured by CASCO NERL Diagnostics. 2. Human serum spiked with salicylate Device description: VALID…	Casco Standards	1991	—
*	—	Human serum spiked with salicylate Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All DKB devices

DKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKB

2in 2014

2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DKB

Too few DKB 510(k)s in any year since 2007 to give a median.

Recalls per year · DKB

2in 2022

2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DKB

1in 2017

2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code DKB, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	2	—	3	0
2010	0	—	0	0
2011	2	—	2	1
2012	1	—	1	4
2013	0	—	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	1
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	2	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033879 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033879: Validate TDM Calibration Verification Test Set, Model 126.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033879

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026