510(k) · Cleared

Cleared

Spotcheck Blood Spot Control, Assayed

K090940510(k) TraditionalCleared Dec 14, 2009255-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

Astoria-Pacific, Inc. · JJT Enzyme Controls (Assayed And Unassayed)

Cleared on Dec 14, 2009 as substantially equivalent to K990827 (Bio-Rad, 1999) after a 255-day review. Its family tree reaches back 2 generations to 1996.

Decided: Dec 14, 2009
Review: 255 days
Class: Class I
Product code: JJT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K961432 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961432 Radias Galt TestBio-Rad · 1996
1 generation backK990827 Microplate Neonatal Galt AssayBio-Rad · 1999
This deviceK090940 Spotcheck Blood Spot Control, AssayedAstoria-Pacific, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961432	Radias Galt Test	Bio-Rad	1996	—
−1	K990827	Microplate Neonatal Galt Assay	Bio-Rad	1999	—
0 (this device)	K090940	Spotcheck Blood Spot Control, Assayed	Astoria-Pacific, Inc.	2009	—

FIG. 1 — Lineage of K090940, 1996–2009Source: 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 JJT? 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
*	K990827	Microplate Neonatal Galt Assay Summary page 2 …intended for use with the MICROPLATE NEONATAL GALT ASSAY kit, item 532-6001 (classification name "fluorescent proc. (qual.), galactose-1 -phosphate uridyl transferase"), K990827. 4. Description of the Device SPOTCHECK Blood Spot Controls CONTENTS: Part No. 80-0900P4K, Blood Spot Controls, Deficient; 4…	Bio-Rad	1999	—

Also cleared against K990827: 2 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?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 10.7 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K990827.

How does its category compare?

All JJT devices

JJT Enzyme Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · JJT

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJT

Too few JJT 510(k)s in any year since 2007 to give a median.

Recalls per year · JJT

1in 2012

2007high 1 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JJT

1in 2011

2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code JJT, 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	0	—	0	1
2008	0	—	0	0
2009	1	—	0	1
2010	0	—	0	1
2011	0	—	0	1
2012	0	—	1	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

SPOTCHECK Blood Spot Controls are used for monitoring assay performance during in vitro diagnostic newborn screening for deficient Galactose-1I-phosphate Uridyltransferase (GALT) and/or Biotinidase enzyme activity. Enzyme response quantitation is provided in the product insert.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090940 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090940: Spotcheck Blood Spot Control, Assayed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090940

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