510(k) · Cleared
ClearedInterlab Alkaline Hemoglobin Electrophoresis Test System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Interlab S.R.L. · JBD System, Analysis, Electrophoretic Hemoglobin
Cleared on Feb 3, 2004 after a 144-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 3, 2004
- Review
- 144 days
- Class
- Class II
- Product code
- JBD
- Recalls
- None
- 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 JBD? 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 |
|---|---|---|---|
| * | — | commercially available agarose gel test system 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JBD devicesJBD System, Analysis, Electrophoretic Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBD
FDA has decided no JBD device since 2007.
Median 510(k) review, days · JBD
Too few JBD 510(k)s in any year since 2007 to give a median.
Recalls per year · JBD
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JBD
2in 2019
MAUDE reports naming product code JBD, 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 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 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 Interlab Alkaline Hemoglobin Electrophoresis test system is intended for the separation of normal hemoglobins(Al, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using cellulose acetate supported on Mylar®. The test is a screening method for in vitro diagnostic use on the Microtech 672 PC and the Microtech 648 ISO fully automated analyzers. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032862 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032862: Interlab Alkaline Hemoglobin Electrophoresis Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032862
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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