510(k) · Cleared
ClearedSpife 2000/3000 Alp 40, 20; Models 3345 and 3346
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helena Laboratories · CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Cleared on May 6, 2002 after a 69-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 6, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- CIN
- 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 CIN? 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 CIN device
- #1 K232904 Access Ostasescore 7.8 · 3 generations · no Class I recall
- #2 Held for the reportin 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 CIN devicesCIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CIN
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CIN
Too few CIN 510(k)s in any year since 2007 to give a median.
Recalls per year · CIN
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CIN
1in 2012
MAUDE reports naming product code CIN, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 3 | 2 |
| 2012 | 0 | — | 3 | 1 |
| 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 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The test system will be used in laboratories to separate serum ALP into the bone, liver, intestine or macrohepatic isoenzymes.
Elevated bone isoenzyme can be found in conditions of physiologic bone growth, osteoporosis and nutritional deficiency such as rickets.
Increased liver isoenzyme values can be seen in hepatitis and cirrhosis of the liver.
Intestinal isoenzymes can be seen in patients with intestinal disease and in individuals of blood type O or B after a meal.
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/K020625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020625: Spife 2000/3000 Alp 40, 20; Models 3345 and 3346.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020625
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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