510(k) · Cleared

Cleared

GSP Neonatal Biotinidase Kit

K131284510(k) TraditionalCleared Nov 14, 2013192-day reviewClass II21 CFR 862.1118

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

Wallac OY · NAK System, Test, Biotinidase

Cleared on Nov 14, 2013 as substantially equivalent to K090123 (Perkinelmer, Inc., 2010) after a 192-day review. Its family tree reaches back 2 generations to 2001.

Decided: Nov 14, 2013
Review: 192 days
Class: Class II
Product code: NAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010844 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010844 Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO.…Astoria-Pacific, Inc. · 2001
1 generation backK090123 Neonatal Biotinidase Kit, Model 3018Perkinelmer, Inc. · 2010
This deviceK131284 GSP Neonatal Biotinidase KitWallac OY · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010844	Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K	Astoria-Pacific, Inc.	2001	—
−1	K090123	Neonatal Biotinidase Kit, Model 3018	Perkinelmer, Inc.	2010	—
0 (this device)	K131284	GSP Neonatal Biotinidase Kit	Wallac OY	2013	—

FIG. 1 — Lineage of K131284, 2001–2013Source: 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 NAK? 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? (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
*	K090123	Neonatal Biotinidase Kit, Model 3018 Summary page 1 …II Panel: 75 Clinical Chemistry Product Code: NAK Predicate device: PerkinElmer Neonatal Biotinidlase kit [K090123] Device Descriuption: The (ISP Neonatal Biotinidlase kit contains sufficient reagents to perform 1152 assays. The (ISP Neonatal…	Perkinelmer, Inc.	2010	—

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 12 years and passes through 3 companies; a new generation was cleared every 8.5 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All NAK devices

NAK System, Test, Biotinidase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NAK

1in 2013

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAK

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

Recalls per year · NAK

No recall names NAK since 2007.

Adverse event reports per year · NAK

1in 2010

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code NAK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	1	—	0
2009	0	—	0
2010	1	—	1
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The GSP Neonatal Biotinidase kit is intended for the quantitative in vitro determination of human biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency using the GSP instrument.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131284 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131284: GSP Neonatal Biotinidase Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131284

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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