510(k) · Cleared

Cleared

Advia Centaur and Acs:180 C-Peptide Calibrator

K021532510(k) TraditionalCleared Jun 27, 200248-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

Bayer Diagnostics Corp. · JIT Calibrator, Secondary

Cleared on Jun 27, 2002 as substantially equivalent to K951848 (Tosoh Medics, Inc., 1996) after a 48-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jun 27, 2002
Review: 48 days
Class: Class II
Product code: JIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951848 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK951848 Aia-Pack CPR AssayTosoh Medics, Inc. · 1996
This deviceK021532 Advia Centaur and Acs:180 C-Peptide CalibratorBayer Diagnostics Corp. · 2002
Descendant · cites it directly · 0 of its ownK082141 Architect C-Peptide Calibrators, and Architect C-Peptide Controls…Biokit, S.A. · 2008

Most influential descendants

Showing 1 of 1 · See all

K082141Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10Biokit, S.A. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951848	Aia-Pack CPR Assay	Tosoh Medics, Inc.	1996	—
0 (this device)	K021532	Advia Centaur and Acs:180 C-Peptide Calibrator	Bayer Diagnostics Corp.	2002	—
+1	K082141	Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models…	Biokit, S.A.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K021532, 1996–2008Source: 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

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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
*	K951848	Aia-Pack CPR Assay Summary page 1 …Phone: +8 1-(3)-3275-1221 Fax: +8 1-(3)-32X- 1214 5 1O(k) Number: K95 1848 6 4. Device Description The ACS: 180 and ADVIA Centaur C-peptide Calibrator is a citric acid buffered sa…	Tosoh Medics, Inc.	1996	—
†	K971998	Advia 120 Hematology System, in Vitro Diagnostic System	Bayer Corp.	1997	2

Also cleared against K951848: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082141	Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10	Biokit, S.A.	2008	0

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.
Of its descendants, K082141 (Biokit, S.A., 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K951848.

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 ACS: 180 and ADVIA Centaur C-peptide calibrators are used for calibrating the ACS: 180 and ADVIA Centaur C-peptide Immunoassays.

The ACS: 180 and ADVIA Centaur C-peptide are sandwich, chemiluminescence immunoassay for the quantitative determination of C-peptide in human serum for use on the automated analyzer marketed by Bayer Corporation. The ACS: 180 and ADVIA Centaur C-peptide Immunoassays can be used to aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021532 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021532: Advia Centaur and Acs:180 C-Peptide Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021532

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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