510(k) · Cleared

Recalled · Class II · 2017

Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01

K061165510(k) TraditionalCleared Aug 3, 200699-day reviewClass II21 CFR 866.5775Recalls 1

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

Sweden Diagnostics (Us), Inc. · NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)

Cleared on Aug 3, 2006 as substantially equivalent to K023285 (Axis-Shield Diagnostics, Ltd., 2002) after a 99-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it. It has been recalled once.

Decided: Aug 3, 2006
Review: 99 days
Class: Class II
Product code: NHX
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K023285 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK023285 Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaAxis-Shield Diagnostics, Ltd. · 2002 · Recalled
This deviceK061165 Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. · 2006
Descendant · cites it directly · 0 of its ownK151799 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid…Phadia AB · 2016

Most influential descendants

Showing 1 of 1 · See all

K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K023285	Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa	Axis-Shield Diagnostics, Ltd.	2002	1
0 (this device)	K061165	Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01	Sweden Diagnostics (Us), Inc.	2006	—
+1	K151799	EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive…	Phadia AB	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K061165, 2002–2016Source: 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 NHX? 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
*	K023285	Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa Summary page 1 …CCP Control NHX II 866.5775 Substantial Equivalence to Axis-Shield Diastat Anti-CCP 510(k) number: K023285 CONFIDENTIAL AND PROPRIETARY Page 64 EliATM CCP - New Device 510(…	Axis-Shield Diagnostics, Ltd.	2002	1

Also cleared against K023285: 4 other devices →

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
K151799	EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…	Phadia AB	2016	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 30, 2017	Class II	Z-1253-2017	Under Investigation by firm	Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
Of its descendants, K151799 (Phadia AB, 2016) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K023285.

How does its category compare?

All NHX devices

NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHX

1in 2016

2007high 3 (2010) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHX

344in 2010

2007high 344 (2010)2026

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

Recalls per year · NHX

No recall names NHX since 2007.

Adverse event reports per year · NHX

3in 2025

2007high 13 (2019) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	2	—	0
2008	2	—	0
2009	2	—	0
2010	3	344	0
2011	2	—	0
2012	0	—	0
2013	1	—	2
2014	0	—	0
2015	1	—	4
2016	1	—	4
2017	0	—	1
2018	0	—	4
2019	0	—	13
2020	0	—	3
2021	0	—	0
2022	0	—	0
2023	0	—	6
2024	0	—	4
2025	0	—	3
2026	0	—	—

What is it indicated for?

EliA CCP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cyclic citrullinated peptides (CCP) in human serum and plasma. The presence of anti-CCP antibodies can be used in conjunction with clinical findings and other laboratory tests as an aid in the clinical diagnosis of rheumatoid arthritis (RA). EliA CCP uses the EliA IgG method on the instruments ImmunoCAP 100 and ImmunoCAP 250.

EliA CCP Control is intended for laboratory use in monitoring the performance of in vitro measurement of anti-cyclic citrullinated peptide (CCP) antibodies with ImmunoCAP using the EliA IgG method.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061165 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061165: Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061165

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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