510(k) · Cleared

Cleared

Aia-Pack HCG Calibration Verification Test Set

K924862510(k) TraditionalCleared Dec 28, 199291-day reviewClass I21 CFR 862.1660

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

Tosoh Medics, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Dec 28, 1992 after a 91-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 55 later devices descend from it.

Decided: Dec 28, 1992
Review: 91 days
Class: Class I
Product code: JJX
Recalls: None
Predicates: 0

55 later devices descend from it, 9 citing it directly.

This deviceK924862 Aia-Pack HCG Calibration Verification Test SetTosoh Medics, Inc. · 1992
Descendant · cites it directly · 32 of its ownK963147 Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996
Descendant · cites it directly · 17 of its ownK963167 Elecys Calcheck T 3Boehringer Mannheim Corp. · 1996
Descendant · 2 generations on · 16 of its ownK111552 Elecsys T3 Calcheck 5Roche Diagnostics · 2011
Descendant · 3 generations on · 15 of its ownK112528 Elecsys T4 Calcheck 5Roche Diagnostics Corporation · 2011
Descendant · 2 generations on · 10 of its ownK974383 Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

1996high 9 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 55 · See all

K963147Elecsys Calcheck TSHBoehringer Mannheim Corp. · 1996 · cites it directly32descendants
K963167Elecys Calcheck T 3Boehringer Mannheim Corp. · 1996 · cites it directly17descendants
K111552Elecsys T3 Calcheck 5Roche Diagnostics · 2011 · 2 generations on16descendants
K112528Elecsys T4 Calcheck 5Roche Diagnostics Corporation · 2011 · 3 generations on15descendants
K974383Elecsys Calcheck Vitamin B12Boehringer Mannheim Corp. · 1997 · 2 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K924862	Aia-Pack HCG Calibration Verification Test Set	Tosoh Medics, Inc.	1992	—
+1	K963147	Elecsys Calcheck TSH	Boehringer Mannheim Corp.	1996	—
+1	K963167	Elecys Calcheck T 3	Boehringer Mannheim Corp.	1996	—
+2	K111552	Elecsys T3 Calcheck 5	Roche Diagnostics	2011	—
+3	K112528	Elecsys T4 Calcheck 5	Roche Diagnostics Corporation	2011	—
+2	K974383	Elecsys Calcheck Vitamin B12	Boehringer Mannheim Corp.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	9	0
1997	6	0
2002	1	0
2004	1	0
2006	1	0
2009	1	0
2010	3	0
2011	6	0
2012	3	0
2013	3	0
2014	7	0
2015	3	0
2016	1	0
2017	3	0
2018	1	0
2019	2	0
2021	1	0
2023	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K924862, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (55)

See all 55

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

Number	Device	Applicant	Decided	Descendants
K963147	Elecsys Calcheck TSH	Boehringer Mannheim Corp.	1996	32
K963167	Elecys Calcheck T 3	Boehringer Mannheim Corp.	1996	17
K963181	Elecsys Calcheck T Update	Boehringer Mannheim Corp.	1996	0
K963165	Elecsys Calcheck HCG	Boehringer Mannheim Corp.	1996	0
K963178	Elecsys Calcheck T4	Boehringer Mannheim Corp.	1996	0
K963163	Elecsys Calcheck FT3	Boehringer Mannheim Corp.	1996	0
K963164	Elecsys Calcheck FT4	Boehringer Mannheim Corp.	1996	0
K963143	Elecsys Calcheck Troponin T	Boehringer Mannheim Corp.	1996	0
K963182	Elecsys Calcheck CK-MB	Boehringer Mannheim Corp.	1996	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?

Of its descendants, K963147 (Boehringer Mannheim Corp., 1996) has gone furthest, with 32 descendants of its own.

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	—

https://510kreport.com/device/K924862 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924862: Aia-Pack HCG Calibration Verification Test Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924862

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026