510(k) · Cleared
ClearedImmage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry System Lamda Light Chain (Lam) Reag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · DFH Kappa, Antigen, Antiserum, Control
Cleared on Feb 10, 1997 as substantially equivalent to K884276 (Beckman Instruments, Inc., 1988) and 2 other predicates after a 108-day review. Its family tree reaches back 1 generation to 1988. 2 later devices descend from it.
- Decided
- Feb 10, 1997
- Review
- 108 days
- Class
- Class II
- Product code
- DFH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K884276 (1988). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK884276 Beckman Kappa Light Chain ReagentBeckman Instruments, Inc. · 1988
- This deviceK964260 Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage…Beckman Instruments, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK083602 Kappa Light ChainsSENTINEL CH. SpA · 2009
- Descendant · cites it directly · 0 of its ownK083601 Lambda Light ChainsSENTINEL CH. SpA · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884276 | Beckman Kappa Light Chain Reagent | Beckman Instruments, Inc. | 1988 | — |
| 0 (this device) | K964260 | Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage… | Beckman Instruments, Inc. | 1997 | — |
| +1 | K083602 | Kappa Light Chains | SENTINEL CH. SpA | 2009 | — |
| +1 | K083601 | Lambda Light Chains | SENTINEL CH. SpA | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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 DFH? 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 DFH device
- #1 K253358 Diazyme Human Kappa (k) Free Light Chain…score 10.5 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K884276 | Beckman Kappa Light Chain ReagentSummary page 1…3.2 Classification Name immunoglobulin (light chain specific) immunological test system (21 CFR § 866.5550) = IMMAGE System Beckman Kappa Light Beckman Instruments, | K884276A Kappa (KAP) Reagent Chain (KAP) Reagent Inc. K902484 IMMAGE System g:"'.““"" La"éb"a Light | Bockman Instruments, | K884597A Lam… | 1988 |
| * | K902484 | Beckman Kappa Light Chain Reagent (Add'l Claims)Summary page 1…pecific) immunological test system (21 CFR § 866.5550) = IMMAGE System Beckman Kappa Light Beckman Instruments, | K884276A Kappa (KAP) Reagent Chain (KAP) Reagent Inc. K902484 IMMAGE System g:"'.““"" La"éb"a Light | Bockman Instruments, | K884597A Lambda (LAM) Reagent | Chain LAM) Reagent | . K902484 Be… | 1990 |
| * | K884597 | Beckman Lambda Light Chain ReagentSummary page 1…m Beckman Kappa Light Beckman Instruments, | K884276A Kappa (KAP) Reagent Chain (KAP) Reagent Inc. K902484 IMMAGE System g:"'.““"" La"éb"a Light | Bockman Instruments, | K884597A Lambda (LAM) Reagent | Chain LAM) Reagent | . K902484 Beckman Instruments, Inc. twx: 910-592-1260 o telex: 06-78413 === Page… | 1988 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 ancestors has a recall.
- Of its descendants, K083602 (SENTINEL CH. SpA, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DFH devicesDFH Kappa, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DFH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DFH
340in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DFH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DFH
10in 2025
MAUDE reports naming product code DFH, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 1 | — | 0 | 4 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 4 | 340 | 0 | 11 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 13 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The IMMAGE Immunochemistry System Kappa (KAP) Reagent, when used in conjunction with Beckman IMMAGE ™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of kappa light chains (free and bound) by rate nephelometry.
The IMMAGE immunochemistry System Lambda (LAM) Reagent, when used in conjunction with Beckman IMMAGE ™ immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of lambda light chains (free and bound) by rate nephelometry.
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/K964260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964260: Immage Immunochemistry System Kappa Light Chain (Kap) Reagent Immage Immunochemistry System Lamda Light Chain (Lam) Reag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964260
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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