510(k) · Cleared

Cleared

Validate Chem 9 Calibration Verification Test Set, Model 109

K023352510(k) TraditionalCleared Nov 22, 200246-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 Nov 22, 2002 as substantially equivalent to K950469 (Casco Standards, 1995) after a 46-day review. Its family tree reaches back 1 generation to 1995.

Decided: Nov 22, 2002
Review: 46 days
Class: Class I
Product code: JJY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950469 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK950469 Document Serum Multianalyte Calibration Verification Test SetCasco Standards · 1995
This deviceK023352 Validate Chem 9 Calibration Verification Test Set, Model 109Maine Standards Co. · 2002

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)	K023352	Validate Chem 9 Calibration Verification Test Set, Model 109	Maine Standards Co.	2002	—

FIG. 1 — Lineage of K023352, 1995–2002Source: 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? (2)

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 …Calibration Verification Classification Name: Calibrator, Multi-Analyte Predicate Devices: 1. DOCUMENT Serum Multi-Analyte CAL-VER, K950469, manufactured by CASCO NERL Diagnostics. 2. Ortho-Clinical Diagnostics VITROS Calibrator Kit 1 Device d…	Casco Standards	1995	—
*	—	Ortho-Clinical Diagnostics VITROS Calibrator Kit 1 Named without a submission number			—

Also cleared against K950469: 17 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
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?

The VALIDATE Chem 9 Calibration Verification Test Set is used by trained laboratory professionals for the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi-automated, and manual clinical chemistry systems for the following eighteen analytes: albumin, calcium, cholesterol, chloride, carbon dioxide, creatinine, glucose, iron, lactate, lithium, magnesium, phosphorus, potassium, sodium, total protein, triglyceride, urea nitrogen, and uric acid.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023352 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023352: Validate Chem 9 Calibration Verification Test Set, Model 109.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023352

Report an extraction error

Are you the manufacturer?

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