510(k) · Cleared
ClearedQuantase Phe/Gal Screening Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantase, Ltd. · JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Cleared on Feb 16, 1999 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 16, 1999
- Review
- 62 days
- Class
- Class II
- Product code
- JNB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JNB? 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
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JNB devicesJNB 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
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 | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 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?
The Quantase Phe/Gal Screening Assay is an enzymatic colorimetric end-point method for the determination of L-phenylalanine and total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening program. The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose concentrations in newborn blood spot specimens. Elevated results…
Read the full statement (121 words)
The Quantase Phe/Gal Screening Assay is an enzymatic colorimetric end-point method for the determination of L-phenylalanine and total D(+)galactose (D(+)galactose + galactose-1-phosphate) in dried blood spot specimens taken from newborn human infants as part of a newborn screening program.
The test is intended as a screening method for measuring the L-phenylalanine and total D(+)galactose concentrations in newborn blood spot specimens. Elevated results are not diagnostic per se of phenylketonuria or galactosemia, but indicate a current need for further study of the newborn from which the positive specimen was received.
The test is NOT for use in monitoring the circulating levels of phenylalanine and total D(+)galactose in phenylketonuric and galactosemic patients respectively, nor to detect ante-natal phenylketonuria and galactosemia or maternal phenylketonuria.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984463: Quantase Phe/Gal Screening Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984463
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026