510(k) · Cleared
ClearedIL Test Amylase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JFJ Catalytic Methods, Amylase
Cleared on Dec 17, 1997 as substantially equivalent to K932467 (Instrumentation Laboratory CO, 1993) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Dec 17, 1997
- Review
- 44 days
- Class
- Class II
- Product code
- JFJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932467 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932467 Ilab 900/1800 Clinical Chemistry SystemInstrumentation Laboratory CO · 1993
- This deviceK974125 IL Test AmylaseInstrumentation Laboratory CO · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932467 | Ilab 900/1800 Clinical Chemistry System | Instrumentation Laboratory CO | 1993 | — |
| 0 (this device) | K974125 | IL Test Amylase | Instrumentation Laboratory CO | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
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 JFJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JFJ device
- #1 K210633 Amylase2score 3.7 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K932467 | Ilab 900/1800 Clinical Chemistry SystemSummary page 1…IL Test™ Amylase Classification name(s): 862.1070 Amylase test systems Class I 75CH Saccharogenic, Amylase Identification of predicate device(s): IL Test™ Amylase = K932467 K943595 — Serum and Urine Claims Added Description of the device/intended use(s): IL Test™ Amylase is an in vitro diagnostic te… | 1993 |
| * | K943595 | Serum/Urine Appli Ilab (TM) Clinical Chemistry SystemSummary page 1…™ Amylase Classification name(s): 862.1070 Amylase test systems Class I 75CH Saccharogenic, Amylase Identification of predicate device(s): IL Test™ Amylase = K932467 K943595 — Serum and Urine Claims Added Description of the device/intended use(s): IL Test™ Amylase is an in vitro diagnostic test for u… | 1994 |
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?
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K932467.
How does its category compare?
All JFJ devicesJFJ Catalytic Methods, Amylase: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JFJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · JFJ
Too few JFJ 510(k)s in any year since 2007 to give a median.
Recalls per year · JFJ
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JFJ
1in 2025
MAUDE reports naming product code JFJ, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IL Test™ Amylase is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of amylase in human serum, plasma or urine by CNP-Maltotrioside methodology. Amylase is used in the diagnosis and treatment of pancreatitis.
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/K974125 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974125: IL Test Amylase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974125
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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