510(k) · Cleared

Recalled · Class II · 2013

Acs:180 and Advia Centaur Ipth Immunoassay

K020217510(k) TraditionalCleared Mar 15, 200252-day reviewClass I21 CFR 862.1660Recalls 4

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

Bayer Diagnostics Corp. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Mar 15, 2002 as substantially equivalent to K954418 (Nichols Institute Diagnostics, 1995) after a 52-day review. Its family tree reaches back 1 generation to 1995. 12 later devices descend from it. It has been recalled 4 times.

Decided: Mar 15, 2002
Review: 52 days
Class: Class I
Product code: JJX
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K954418 (1995). 12 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK954418 Intact Parathyroid Hormone (PTH) Immunoassay (Modification)Nichols Institute Diagnostics · 1995
This deviceK020217 Acs:180 and Advia Centaur Ipth ImmunoassayBayer Diagnostics Corp. · 2002
Descendant · cites it directly · 5 of its ownK133124 Immulite 2000; Total T3 Calibration Verification Material, Total T4…Siemens Healthcare Diagnostics, Inc. · 2013
Descendant · cites it directly · 4 of its ownK132515 Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013
Descendant · 2 generations on · 3 of its ownK141463 Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014
Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
Descendant · 3 generations on · 1 of its ownK182698 LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON…DiaSorin, Inc. · 2018

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2013high 4 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 12 · See all

K133124Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…Siemens Healthcare Diagnostics, Inc. · 2013 · cites it directly5descendants
K132515Liaison N-Tact PTH Gen II, Control Set, Calibration VerifiersDiaSorin, Inc. · 2013 · cites it directly4descendants
K141463Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration VerifiersDiaSorin, Inc. · 2014 · 2 generations on3descendants
K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc. · 2018 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954418	Intact Parathyroid Hormone (PTH) Immunoassay (Modification)	Nichols Institute Diagnostics	1995	—
0 (this device)	K020217	Acs:180 and Advia Centaur Ipth Immunoassay	Bayer Diagnostics Corp.	2002	—
+1	K133124	Immulite 2000; Total T3 Calibration Verification Material, Total T4…	Siemens Healthcare Diagnostics, Inc.	2013	—
+1	K132515	Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers	DiaSorin, Inc.	2013	—
+2	K141463	Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers	DiaSorin, Inc.	2014	—
+2	K140818	Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…	Siemens Healthcare Diagnostics, Inc.	2014	—
+3	K182698	LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin…	DiaSorin, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	3	0
2014	4	0
2015	2	0
2018	2	0
2022	1	0

FIG. 1 — Lineage of K020217, 1995–2022Source: 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 JJX? 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
*	K954418	Intact Parathyroid Hormone (PTH) Immunoassay (Modification) Summary page 1 …Nichols Institute Diagnostics Intact Parathyroid Hormone (PTH) kit / Nichols IRMA Intact PTH Nichols Institute Diagnostics 33608 Ortega Highway San Juan Capistrano, Ca K954418 4. Device Description The ACS:180 Intact PTH assay is a two-site “sandwich” immunoassay using direct, chemilumin…	Nichols Institute Diagnostics	1995	—

Also cleared against K954418: 1 other device →

What descends from it? (12)

See all 12

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133124	Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration…	Siemens Healthcare Diagnostics, Inc.	2013	5
K132515	Liaison N-Tact PTH Gen II, Control Set, Calibration Verifiers	DiaSorin, Inc.	2013	4
K132391	Immulite 2000 Anti-TG AB Calibration Verification Material, Immulite 2000 Anti-Tpo AB…	Siemens Helathcare Diagnostics, Inc.	2013	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 16, 2013	Class III	Z-0173-2014	Packaging	PTH Calibrator packaged with only high calibrator.
May 14, 2013	Class II	Z-1514-2013	No Marketing Application	iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
May 14, 2013	Class II	Z-1515-2013	No Marketing Application	iPTH Assay- reagent and calibrator lots may have demonstrated higher than anticipated variability
Oct 3, 2008	Not classified	Z-1186-2012	Process control	Poor sensitivity and imprecision on ADVIA Centaur systems; Serum samples low bias; EDTA plasma samples low bias

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K133124 (Siemens Healthcare Diagnostics, Inc., 2013) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K954418.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, 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	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

The ACS:180 and ADVIA Centaur Intact PTH Immunoassay is intended for the quantitative

determination of intact parathyroid hormone in human EDTA plasma on the automated ACS:180 and

ADVIA Centaur analyzers marketed by Bayer Corporation. Intact PTH levels can be used to aide in the

differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K020217 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020217: Acs:180 and Advia Centaur Ipth Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020217

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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