510(k) · Cleared

Cleared

Document Thyroid Cal*Ver

K992034510(k) TraditionalCleared Jul 23, 199937-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

Casco-Nerl Diagnostics Corporation (Maine) · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Jul 23, 1999 as substantially equivalent to K950469 (Casco Standards, 1995) after a 37-day review. Its family tree reaches back 1 generation to 1995. 29 later devices descend from it.

Decided: Jul 23, 1999
Review: 37 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950469 (1995). 29 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
This deviceK992034 Document Thyroid Cal*VerCasco-Nerl Diagnostics Corporation (Maine) · 1999
Descendant · cites it directly · 26 of its ownK062501 Validate Thyroid Calibration Verification / Linearity Test Set…Maine Standards Co. · 2006
Descendant · 2 generations on · 18 of its ownK102904 Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010
Descendant · 3 generations on · 14 of its ownK110061 CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011
Descendant · 4 generations on · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
Descendant · 5 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

1999high 10 (2014) · low 0 (2000)2026

Most influential descendants

Showing 5 of 29 · See all

K062501Validate Thyroid Calibration Verification / Linearity Test Set, Model 901Maine Standards Co. · 2006 · cites it directly26descendants
K102904Enhanced Estradiol (EE2) Master Curve MaterialSiemens Healthcare Diagnostics · 2010 · 2 generations on18descendants
K110061CVM, Unconjugated Estriol (UE3) Calibration Verification MaterialSiemens Healthcare Diagnostics · 2011 · 3 generations on14descendants
K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · 4 generations on13descendants
K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 5 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950469	Document Serum Multianalyte Calibration Verification Test Set	Casco Standards	1995	—
0 (this device)	K992034	Document Thyroid Cal*Ver	Casco-Nerl Diagnostics Corporation (Maine)	1999	—
+1	K062501	Validate Thyroid Calibration Verification / Linearity Test Set, Model 901	Maine Standards Co.	2006	—
+2	K102904	Enhanced Estradiol (EE2) Master Curve Material	Siemens Healthcare Diagnostics	2010	—
+3	K110061	CVM, Unconjugated Estriol (UE3) Calibration Verification Material	Siemens Healthcare Diagnostics	2011	—
+4	K133128	Immulite 2000; HCG Calibration Verification Material, Insulin Calibration…	Siemens Healthcare Diagnostics, Inc.	2013	—
+5	K140258	Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration…	Siemens Healthcare Diagnostics, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2004	1	0
2006	1	0
2009	3	0
2010	1	0
2011	3	0
2013	2	0
2014	10	0
2015	5	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K992034, 1995–2020Source: 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 JJY? 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
*	K950469	Document Serum Multianalyte Calibration Verification Test Set Summary page 1 …alibration Verification Quality Control Material Control, Multianalyte Assayed (21 CFR §862.1660) DOCUMENT Serum Multianalyte Calibration Verification Test Set 510(k) #K950469 Classification Name: Predicate Device: Description of the Device: DOCUMENT Thyroid CAL « VER contains assayed solutions of the…	Casco Standards	1995	—

Also cleared against K950469: 17 other devices →

What descends from it? (29)

See all 29

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

Number	Device	Applicant	Decided	Descendants
K062501	Validate Thyroid Calibration Verification / Linearity Test Set, Model 901	Maine Standards Co.	2006	26
K041073	Document Salicylate Cal Ver	Microgenics Corp.	2004	0
K993014	Modification to Document Thyroid Cal.Ver	Casco-Nerl Diagnostics Corporation (Maine)	1999	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, K062501 (Maine Standards Co., 2006) has gone furthest, with 26 descendants of its own.
17 other devices also cite its predicate K950469.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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	11	49	5	2
2008	7	54	0	1
2009	8	80	2	3
2010	10	109	6	3
2011	14	120	1	6
2012	13	40	3	20
2013	16	82	2	5
2014	10	49	2	4
2015	4	153	1	4
2016	1	—	3	13
2017	3	78	4	12
2018	0	—	3	7
2019	0	—	4	1
2020	0	—	6	7
2021	0	—	0	1
2022	0	—	3	0
2023	0	—	3	4
2024	0	—	0	1
2025	0	—	2	13
2026	0	—	1	—

What is it indicated for?

DOCUMENT Thyroid CAL « VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3) and Thyroid Stimulating Hormone (TSH).

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/K992034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992034: Document Thyroid Cal*Ver.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992034

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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