510(k) Report

510(k) · Cleared

Cleared

Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin Electrophoresis Test System

K053571510(k) TraditionalCleared Jun 30, 2006190-day reviewClass II21 CFR 864.7440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Interlab S.R.L. · JBD System, Analysis, Electrophoretic Hemoglobin

Cleared on Jun 30, 2006 after a 190-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jun 30, 2006
Review
190 days
Class
Class II
Product code
JBD
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K053571Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
Get a 510(k) 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 JBD devices

JBD 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

2018: 1
2007high 1 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JBD

2in 2019

2019: 2
2007high 2 (2019) · low 0 (2007)2025

MAUDE reports naming product code JBD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—10
20190—02
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semi-quantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary. The electrophoretic test is performed at alkaline pH and provides a valuable…

Read the full statement (170 words)

The Microgel Alkaline Hemoglobin Electrophoresis test kit is intended for qualitative and semi-quantitative determination of normal hemoglobins (A1, A2 and F) as well as certain abnormal or variant hemoglobins (S or D and C or E) using agarose gel. To distinguish hemoglobins S from D or C from E an alternate confirmatory test such as acid hemoglobin electrophoresis is necessary. The electrophoretic test is performed at alkaline pH and provides a valuable screening method for hemoglobin patterns. Densitometry of the pattern allows the relative quantification of hemoglobin bands. The kit SRE604K has been designed for use with the fully automated Microgel instrument.

The Microgel Acid Hemoglobin Electrophoresis kit is a qualitative test for the identification of both normal and abnormal or variant hemoglobins, and to confirm the identity of clinically relevant hemoglobins such as A, F, S and C. The Acid Hemoglobin test kit employs agarose gel at acidic pH and is for in vitro diagnostic use. The kit has been designed for use with the fully automated Microgel instrument.

Indications for use as stated in the FDA 510(k) statement.

More from Interlab S.R.L.

4 FDA decisions under this applicant name. See the company

  • K040146Interlab Acid Hemoglobin Electrophoresis Test SystemInterlab S.R.L. · 2004
  • K032862Interlab Alkaline Hemoglobin Electrophoresis Test SystemInterlab S.R.L. · 2004
  • K033187Interlab Immunofixation Test (S)Interlab S.R.L. · 2003

Recent decisions in JBD

The JBD category page

  • K032862Interlab Alkaline Hemoglobin Electrophoresis Test SystemInterlab S.R.L. · 2004
  • K992199Acid Hemoglobin KitHelena Laboratories · 1999
  • K991362Hydragel Hemoglobin (E), Mini Hemoglobin (E), 7 Hemoglobin (E), 15 Hemoglobin (E), Acid (E) Hemoglobin (E)…Morax · 19991 recall
  • K982426Spife Alkaline HemoglobinHelena Laboratories · 19981 recall
  • K931503Rep Hemoglobin Ief Kits (Cat. NO. 3250)Helena Laboratories · 1993

https://510kreport.com/device/K053571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053571: Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin Electrophoresis Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053571

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026