510(k) · Cleared

Cleared

Spotcheck Neonatal Galt Microplate Reagent Kit

K102643510(k) TraditionalCleared Jul 15, 2011304-day reviewClass II21 CFR 862.1315

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

Astoria-Pacific, Inc. · KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

Cleared on Jul 15, 2011 as substantially equivalent to K990827 (Bio-Rad, 1999) and 1 other predicate after a 304-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jul 15, 2011
Review: 304 days
Class: Class II
Product code: KQP
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K961432 (1996). 3 ancestors in all, the oldest K953710 (1995). 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 deviceK102643 Spotcheck Neonatal Galt Microplate Reagent KitAstoria-Pacific, Inc. · 2011

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)	K102643	Spotcheck Neonatal Galt Microplate Reagent Kit	Astoria-Pacific, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K102643, 1996–2011Source: 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 KQP? 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? (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
*	K990827	Microplate Neonatal Galt Assay Summary page 2 …keted device for which substantial equivalence is claimed. Product Classification Reagent Kit Regulation Number 21 CFR 862.1315 510O(k) Number K990827 Classification Panel Clinical Chemistry Product Code KQP Device Classification Class 11 Product Nomenclature…	Bio-Rad	1999	—
*	K953710	ELX808 Automated Microplate Readers Summary page 2 …. 532-6000, 192 Test Kit Bio-Rad Part No. 532-6001, 960 Test Kit Instrument Regulation Number 21 CFR 862.2300 510(k) Number K953710 Classification Panel Clinical Chemistry Product Code JJQ Device Classification Class I Product Nomenclature…	Bio-Tek Instruments, Inc.	1995	1

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 15 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K990827.

How does its category compare?

All KQP devices

KQP Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KQP

2in 2011

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KQP

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

Recalls per year · KQP

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · KQP

No MAUDE report names KQP since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	2	—	0	0
2012	0	—	0	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	—	1	—

What is it indicated for?

The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1 -phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening…

Read the full statement (136 words)

This device is intended for use by trained, qualified laboratory personnel.

The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements.

This device and assays are intended for use by trained, qualified laboratory personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102643 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102643: Spotcheck Neonatal Galt Microplate Reagent Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102643

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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