Quantase Phenylalanine Screening Assay 500 Test Kit

K000754510(k) TraditionalCleared Jun 19, 2000103-day reviewClass II21 CFR 862.1555Recalls 1

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

Quantase, Ltd. · JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Cleared on Jun 19, 2000 after a 103-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled once.

Decided: Jun 19, 2000
Review: 103 days
Class: Class II
Product code: JNB
Recalls: 1
Predicates: 0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K000754Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 26, 2010	Not classified	Z-1562-2011	Other	Pressure contained within the Elution Buffer vial may expel the rubber stopper, causing the potential for injury.

No ancestor or descendant has a Class I recall.

How does its category compare?

All JNB devices

JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JNB

FDA has decided no JNB device since 2007.

Median 510(k) review, days · JNB

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

Recalls per year · JNB

1in 2012

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JNB

No MAUDE report names JNB since 2007.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	1	0
2011	—	0	0
2012	—	1	0
2013	—	0	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	—

https://510kreport.com/device/K000754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000754: Quantase Phenylalanine Screening Assay 500 Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000754

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026