510(k) · Cleared
Recalled · Class II · 2012Neogram Pku Tandem Mass Spectrometry Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Perkinelmer Life Sciences · JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Cleared on Oct 28, 2002 after a 171-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Oct 28, 2002
- Review
- 171 days
- Class
- Class II
- Product code
- JNB
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 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? (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 | Decided |
|---|---|---|---|
| * | — | Isolab Phenylalanine Test Kit Named without a submission number |
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 |
|---|---|---|---|---|
| Nov 26, 2012 | Class II | Z-0686-2013 | Process control | Truncated V-Bottomed Microplate Wells used in assays contain defective wells. |
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 kit is intended for screening for phenylketonuria (PKU). It involves the quantitative determination of phenylalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021541: Neogram Pku Tandem Mass Spectrometry Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021541
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026