510(k) · Cleared

Cleared

The Emit 2000 Tacrolimus Calibrators

K060371510(k) TraditionalCleared Mar 9, 200624-day reviewClass II21 CFR 862.1150

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

Dade Behring, Inc. · JIT Calibrator, Secondary

Cleared on Mar 9, 2006 as substantially equivalent to P970007 (Abbott Laboratories, 1997) after a 24-day review. Its family tree reaches back 1 generation to 1997.

Decided: Mar 9, 2006
Review: 24 days
Class: Class II
Product code: JIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to P970007 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backP970007 Imx Tacrolimus II AssayAbbott Laboratories · 1997 · Recalled
This deviceK060371 The Emit 2000 Tacrolimus CalibratorsDade Behring, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	P970007	Imx Tacrolimus II Assay	Abbott Laboratories	1997	2
0 (this device)	K060371	The Emit 2000 Tacrolimus Calibrators	Dade Behring, Inc.	2006	—

FIG. 1 — Lineage of K060371, 1997–2006Source: 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 JIT? 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? (1)

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
*	P970007	Imx Tacrolimus II Assay Summary page 1 …e Name / Classification Emit® 2000 Tacrolimus Calibrators /Class II 3. Identification of the Predicate Device Abbott IMx® Tacrolimus 11 Calibrators, P970007 (Note: Tacrolimus test systems have been reclassified into Class II since the predicate was approved.) 4. Devi…	Abbott Laboratories	1997	2

Also cleared against P970007: 4 other devices →

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 a recall.
4 other devices also cite its predicate P970007.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIT

7in 2017

2007high 10 (2014) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIT

28in 2017

2007high 140 (2013) · low 28 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JIT

1in 2023

2007high 5 (2018) · low 0 (2008)2026

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

Adverse event reports per year · JIT

7in 2025

2007high 215 (2019) · low 0 (2007)2025

MAUDE reports naming product code JIT, 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	5	78	1	0
2008	6	46	0	0
2009	2	—	2	0
2010	6	65	0	3
2011	7	48	3	2
2012	2	—	3	10
2013	5	140	0	43
2014	10	33	2	9
2015	4	30	1	6
2016	4	33	0	3
2017	7	28	0	7
2018	0	—	5	8
2019	0	—	0	215
2020	0	—	2	12
2021	0	—	0	3
2022	0	—	0	4
2023	0	—	1	6
2024	0	—	0	17
2025	0	—	0	7
2026	0	—	1	—

What is it indicated for?

The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060371 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060371: The Emit 2000 Tacrolimus Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060371

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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