510(k) · Cleared
ClearedImmage Systems Low Concentration Immunoglobulin a Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CZP Iga, Antigen, Antiserum, Control
Cleared on Feb 13, 2006 as substantially equivalent to K993549 (Beckman Coulter, Inc., 2000) after a 26-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Feb 13, 2006
- Review
- 26 days
- Class
- Class II
- Product code
- CZP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771603 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
- 2 generations backK963868 Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M…Beckman Instruments, Inc. · 1997 · Recalled
- 1 generation backK993549 Beckman Coulter Immage Immunochemistry System Low Concentration…Beckman Coulter, Inc. · 2000
- This deviceK060130 Immage Systems Low Concentration Immunoglobulin a ReagentBeckman Coulter, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771603 | Immochemistry System | Beckman Instruments, Inc. | 1977 | — |
| −2 | K963868 | Immage Immunochemistry System Immunoglobulin G (Igg), a (Iga) and M (Igm) | Beckman Instruments, Inc. | 1997 | 2 |
| −1 | K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin… | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K060130 | Immage Systems Low Concentration Immunoglobulin a Reagent | Beckman Coulter, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 CZP? 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 CZP device
- #1 K193525 Yumizen C1200 Immunoglobulin A, Yumizen C1200…score 0.2 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K993549 | Beckman Coulter Immage Immunochemistry System Low Concentration Immunoglobulin a (Igalc)…Summary page 1…claims substantial equivalence to the IMMAGE Systems Low Concentration Immunoglobulin A Reagent currently in commercial distribution. (FDA 510(k) Number K993549) 5.0 Device Description The IMMAGE® Low Concentration Immunoglobulin A (IGALC) Reagent and Cerebrospinal Fl… | 2000 |
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?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K993549.
How does its category compare?
All CZP devicesCZP Iga, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CZP
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · CZP
Too few CZP 510(k)s in any year since 2007 to give a median.
Recalls per year · CZP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CZP
1in 2025
MAUDE reports naming product code CZP, 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 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IGALC reagent, when used in conjunction with IMMAGE® Immunochemistry Systems and Cerebrospinal Fluid Protein Calibrator, is intended for quantitative determination of Low Concentration Immunoglobulin A (IGALC) in human serum or cerebrospinal fluid (CSF) by rate nephelometry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060130 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060130: Immage Systems Low Concentration Immunoglobulin a Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060130
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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