510(k) · Cleared

Recalled · Class II · 2013

Loci Cardiac Troponin I Calibrator, Model RC621

K081683510(k) TraditionalCleared Jul 7, 200820-day reviewClass II21 CFR 862.1150Recalls 3

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

Siemens Healthcare Diagnostics · JIT Calibrator, Secondary

Cleared on Jul 7, 2008 as substantially equivalent to K053577 (Dade Behring, Inc., 2006) after a 20-day review. Its family tree reaches back 2 generations to 2001. It has been recalled 3 times.

Decided: Jul 7, 2008
Review: 20 days
Class: Class II
Product code: JIT
Recalls: 3
Predicates: 1

Its longest line of descent runs back 2 generations to K010313 (2001). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010313 Dimension Ctni Flex Reagent CartridgeDade Behring, Inc. · 2001 · Recalled
1 generation backK053577 Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and…Dade Behring, Inc. · 2006
This deviceK081683 Loci Cardiac Troponin I Calibrator, Model RC621Siemens Healthcare Diagnostics · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010313	Dimension Ctni Flex Reagent Cartridge	Dade Behring, Inc.	2001	2
−1	K053577	Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample…	Dade Behring, Inc.	2006	—
0 (this device)	K081683	Loci Cardiac Troponin I Calibrator, Model RC621	Siemens Healthcare Diagnostics	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K081683, 2001–2008Source: 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

Get a 510(k) Report

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
*	K053577	Dimension Vista Ctni Flex Flex Reagent Cartridge, Calibrator and Sdil Sample Diluent Summary page 1 …e LOCI® Cardiac Troponin I Calibrator/ 21 CFR 862.1150 3. Identification of the Predicate Device Dimension Vista® Cardiac Troponin I Calibrator, K053577 4. Device Description The LOCI® Cardiac Troponin I Calibrator is a liquid, frozen, human serum based prod…	Dade Behring, Inc.	2006	—

Also cleared against K053577: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 17, 2013	Class II	Z-1926-2014	Process control	Siemens Dimension LOCI TNI Troponin I calibrator lot 3DD007 may demonstrate an average upward shift of 24% in QC and patient results following calibration.
Nov 17, 2011	Not classified	Z-0513-2012	Nonconforming Material/Component	Siemens Healthcare Diagnostics has confirmed positive bias on QC and Patients.
Aug 31, 2011	Not classified	Z-0038-2012	Other	Internal testing has confirmed that recovery of levels 2 and 3 of LOCl Cardiac Troponin I Calibrator is lower than expected bottle value. Following calibration with LOCl Cardiac Troponin I Calibrator, lot 1AD045 an upward shift in patient…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
1 of the 3 ancestors has a recall of any class.
1 other device also cites its predicate K053577.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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 LOCI® TNI CAL is an in vitro diagnostic product for the calibration of the Cardiac Troponin I (TNI) method on the Dimension® EXLTM integrated chemistry system with LOCI® module.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081683 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081683: Loci Cardiac Troponin I Calibrator, Model RC621.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081683

Report an extraction error

Are you the manufacturer?

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