510(k) · Cleared
ClearedDelfia Neonatal Irt Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wallac OY · CGZ Electrode, Ion-Specific, Chloride
Cleared on Jun 9, 2000 as substantially equivalent to K791202 (Cis Radiopharmaceuticals, Inc., 1979) after a 220-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Jun 9, 2000
- Review
- 220 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K791202 (1979). No later device cites it as a predicate yet.
- Root · 1 generation backK791202 Ria Kit for TrypsinCis Radiopharmaceuticals, Inc. · 1979 · Recalled
- This deviceK993697 Delfia Neonatal Irt KitWallac OY · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791202 | Ria Kit for Trypsin | Cis Radiopharmaceuticals, Inc. | 1979 | 1 |
| 0 (this device) | K993697 | Delfia Neonatal Irt Kit | Wallac OY | 2000 | — |
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 CGZ? 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 |
|---|---|---|---|
| * | K791202 | Ria Kit for TrypsinSummary page 1…tal IRT kit Common Name: Fluoroimmunoassay for the determination of immunoreactive trypsin Classification Name: Trypsin test system Predicate Device: Trypsik I RIA kit (K 791202) Device Description: The DELFIA® Neonatal immunoreactive trypsin (IRT) assay is a solid phase, two-site fluoro-immunometric ass… | 1979 |
| † | K853973 | Wescor Model 3700 Webster Sweat Inducer | 1985 |
| † | K840472 | Sys Macroduct Sweat Collection Sys 3600 | 1984 |
| † | K863395 | Wescor Sweat.Chek Sweat Conductivity Analyzer | 1988 |
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?
- Its one ancestor has a recall.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This kit is intended for the quantitative determination of immunoreactive trypsin (IRT) in blood specimens dried on filter paper as an aid in screening newborns for cystic fibrosis.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993697: Delfia Neonatal Irt Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993697
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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