510(k) · Cleared

Cleared

Validate Chem 4 Calibration Verification Test Set, Model 10004

K012120510(k) TraditionalCleared Aug 20, 200145-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

Maine Standards Co. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Aug 20, 2001 as substantially equivalent to K932458 (Casco Standards, 1993) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1986. 3 later devices descend from it.

Decided: Aug 20, 2001
Review: 45 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K863751 (1986). 3 ancestors in all. 3 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK863751 Multi-Analyte Lin-TrolSigma Diagnostics, Inc. · 1986
This deviceK012120 Validate Chem 4 Calibration Verification Test Set, Model 10004Maine Standards Co. · 2001
Descendant · cites it directly · 1 of its ownK091225 Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity…Maine Standards Co. · 2009
Descendant · 2 generations on · 0 of its ownK153712 VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification…Radiometer America, Inc. · 2016
Descendant · cites it directly · 0 of its ownK041975 Validate Lipoprotein Calibration Verification Test Set, Model 501Maine Standards Co. · 2004

Most influential descendants

Showing 3 of 3 · See all

K091225Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test SetMaine Standards Co. · 2009 · cites it directly1descendant
K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…Radiometer America, Inc. · 2016 · 2 generations on0descendants
K041975Validate Lipoprotein Calibration Verification Test Set, Model 501Maine Standards Co. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K863751	Multi-Analyte Lin-Trol	Sigma Diagnostics, Inc.	1986	—
0 (this device)	K012120	Validate Chem 4 Calibration Verification Test Set, Model 10004	Maine Standards Co.	2001	—
+1	K091225	Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set	Maine Standards Co.	2009	—
+2	K153712	VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7…	Radiometer America, Inc.	2016	—
+1	K041975	Validate Lipoprotein Calibration Verification Test Set, Model 501	Maine Standards Co.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2009	1	0
2016	1	0

FIG. 1 — Lineage of K012120, 1986–2016Source: 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 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

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What was it cleared against? (3)

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
*	K932458	Document Enzyme Summary page 1 …on Verification Test Set Common Name: Calibration Verification Classification Name: Calibrator, Multi-Analyte Predicate Devices: 1. DOCUMENT Enzyme Linearity Test Set, K932458, manufactured by CASCO NERL Diagnostics. , 2. DOCUMENT Total/Direct Bilirubin Test Set, K924493, manufactured by CASCO NERL Diag…	Casco Standards	1993	—
*	K924493	Document Total and Direct Bilirubin Linearity-Mod Summary page 1 …ulti-Analyte Predicate Devices: 1. DOCUMENT Enzyme Linearity Test Set, K932458, manufactured by CASCO NERL Diagnostics. , 2. DOCUMENT Total/Direct Bilirubin Test Set, K924493, manufactured by CASCO NERL Diagnostics. 3. Lipase LIN-TROL, K863751, manufactured by Sigma Diagnostics, Inc. Device descriptio…	Casco Standards	1993	—
*	K863751	Multi-Analyte Lin-Trol Summary page 1 …t, K932458, manufactured by CASCO NERL Diagnostics. , 2. DOCUMENT Total/Direct Bilirubin Test Set, K924493, manufactured by CASCO NERL Diagnostics. 3. Lipase LIN-TROL, K863751, manufactured by Sigma Diagnostics, Inc. Device description: VALIDATE Chem 4 Calibration Verification Test Set contains purified…	Sigma Diagnostics, Inc.	1986	—

What descends from it? (3)

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

Number	Device	Applicant	Decided	Descendants
K091225	Validate GC1, GC2, GC3 and GC4 Calibration Verification/Linearity Test Set	Maine Standards Co.	2009	1
K041975	Validate Lipoprotein Calibration Verification Test Set, Model 501	Maine Standards Co.	2004	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?

None of the 3 ancestors has a recall.
Of its descendants, K091225 (Maine Standards Co., 2009) has gone furthest, with 1 descendant of its own.

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?

The VALIDATE Chem 4 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity of automated, semi-automated and manual chemistry systems for the following analytes: alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, creatine kinase, gamma-glutamyl transferase, lactate dehydrogenase, lipase, total bilirubin and direct bilirubin.

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/K012120 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012120: Validate Chem 4 Calibration Verification Test Set, Model 10004.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012120

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026