510(k) · Cleared

Cleared

Neonatal Biotinidase Kit, Model 3018

K090123510(k) TraditionalCleared Mar 5, 2010408-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

Perkinelmer, Inc. · NAK System, Test, Biotinidase

Cleared on Mar 5, 2010 as substantially equivalent to K010844 (Astoria-Pacific, Inc., 2001) after a 408-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Mar 5, 2010
Review: 408 days
Class: Class II
Product code: NAK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010844 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010844 Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO.…Astoria-Pacific, Inc. · 2001
This deviceK090123 Neonatal Biotinidase Kit, Model 3018Perkinelmer, Inc. · 2010
Descendant · cites it directly · 0 of its ownK131284 GSP Neonatal Biotinidase KitWallac OY · 2013

Most influential descendants

Showing 1 of 1 · See all

K131284GSP Neonatal Biotinidase KitWallac OY · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K090123, 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
*	K010844	Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part NO. 80-8000-13K Summary page 2 …e semi-quantitative SPOTCHECK Biotinidase 50 determination of biotinidase Hour Reagent Kit (k010844) is activity in blood specimens dried intended for the semi-quantitative…	Astoria-Pacific, Inc.	2001	—

Also cleared against K010844: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131284	GSP Neonatal Biotinidase Kit	Wallac OY	2013	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?

Its one ancestor has no recall.
Of its descendants, K131284 (Wallac OY, 2013) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K010844.

How does its category compare?

All NAK devices

NAK System, Test, Biotinidase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Neonatal Biotinidase kit is intended for the semi-quantitative determination of biotinidase activity in blood specimens dried on filter paper as an aid in screening newborns for biotinidase deficiency.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090123 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090123: Neonatal Biotinidase Kit, Model 3018.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090123

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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