510(k) Report

510(k) · Cleared

Recalled · 2010

Immage Immunochemistry System

K962294510(k) TraditionalCleared Aug 21, 199668-day reviewClass I21 CFR 862.2700Recalls 2

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

Beckman Instruments, Inc. · JQX Nephelometer, For Clinical Use

Cleared on Aug 21, 1996 as substantially equivalent to K922273 (Beckman Instruments, Inc., 1992) and 9 other predicates after a 68-day review. Its family tree reaches back 1 generation to 1977. It has been recalled 2 times.

Decided
Aug 21, 1996
Review
68 days
Class
Class I
Product code
JQX
Recalls
2
Predicates
10

Its longest line of descent runs back 1 generation to K771603 (1977). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1993: 2 other ancestors1992: 2 other ancestors1988: 1 other ancestor1986: 1 other ancestor1981: 1 other ancestor1978: 1 other ancestorK771603 · Immochemistry System · Beckman Instruments, Inc. · 197719751980198519901995
Other ancestors, by generation 1 generation back: 9 other ancestors K771603 · Immochemistry System · Beckman Instruments, Inc. · 19770
  1. Root · 1 generation backK771603 Immochemistry SystemBeckman Instruments, Inc. · 1977
  2. This deviceK962294 Immage Immunochemistry SystemBeckman Instruments, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K771603Immochemistry SystemBeckman Instruments, Inc.1977—
0 (this device)K962294Immage Immunochemistry SystemBeckman Instruments, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198110
198610
198810
199220
199320
199410
FIG. 1 — Lineage of K962294, 1977–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 JQX? 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? (10)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K922273Array (R) 360
Summary page 1
…21 CFR 862.2700) Discrete photometric chemistry analyzer for clinical use (21 CFR 862.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882…
Beckman Instruments, Inc.1992—
*K771603Immochemistry System
Summary page 1
…2.2700) Discrete photometric chemistry analyzer for clinical use (21 CFR 862.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932…
Beckman Instruments, Inc.1977—
*K780913Additional Reagents Kits for Imm. System
Summary page 1
…iscrete photometric chemistry analyzer for clinical use (21 CFR 862.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Beh…
Beckman Instruments, Inc.1978—
*K926272Beckman Transferrin Kit
Summary page 1
…hotometric chemistry analyzer for clinical use (21 CFR 862.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N La…
Beckman Instruments, Inc.1993—
*K862019Ics Apolipoprotein a-1 Reagent Test Kit
Summary page 1
…c chemistry analyzer for clinical use (21 CFR 862.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K…
Beckman Instruments, Inc.1986—
*K810306Rheumatoid Factor Reagent Test Kit
Summary page 1
…ry analyzer for clinical use (21 CFR 862.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328)…
Beckman Instruments, Inc.1981—
*K924186Lpia-Ferritin Assay
Summary page 1
…2.2160) Predicate Device(s) Beckman ARRAY® 360 Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328) Description The IMMAGE Immunochemistry…
Seradyn, Inc.1992—
*K882233TDX (R) Digoxin NXT
Summary page 1
…Immunochemistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328) Description The IMMAGE Immunochemistry System is a fully automated, computer controlled…
Abbott Laboratories1988—
*K932127TDX/Tdxflx & Tdxflx Theophylline Monoclonal II
Summary page 1
…mistry System and Reagents (K922273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328) Description The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-t…
Abbott Laboratories1993—
*K942328N Latex RF
Summary page 1
…22273, K771603, K780913, K926272, K862019, K810306) Seradyn LPIA-100 Instrument (K924186/A) Abbott TDx Immunochemistry Reagents (K882233, K932127) Behring N Latex RF (K942328) Description The IMMAGE Immunochemistry System is a fully automated, computer controlled, bench-top chemistry analyzer intended…
Behring Diagnostics, Inc.1994—

Also cleared against K922273: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 24, 2010Not classifiedZ-2045-2011OtherThe recall was initiated because Beckman Coulter has confirmed an Immage Systems Wash Solution Lot 71744 was manufactured by a Beckman European facility and not intended to be used in the U.S. However, this lot was inadvertently shipped…
May 21, 2010Not classifiedZ-2195-2010Nonconforming Material/ComponentBeckman Coulter is initiating a recall of IMMAGE Immunochemistry Systems Buffer 1 (BUF1) due to received reports of increased recovery of control and patient samples using the lots of IMMAGE BUF1. Some lots of BUF1 have been reported to…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 10 ancestors has a recall.
  • 7 other devices also cite its predicate K922273.

How does its category compare?

All JQX devices

JQX Nephelometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JQX

FDA has decided no JQX device since 2007.

Median 510(k) review, days · JQX

Too few JQX 510(k)s in any year since 2007 to give a median.

Recalls per year · JQX

1in 2017

2010: 12017: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JQX

18in 2025

2009: 22010: 142011: 372012: 162013: 12014: 12018: 12019: 12020: 102021: 122022: 242023: 272024: 782025: 18
2007high 78 (2024) · low 0 (2007)2025

MAUDE reports naming product code JQX, 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—02
20100—114
20110—037
20120—016
20130—01
20140—01
20150—00
20160—00
20170—10
20180—01
20190—01
20200—010
20210—012
20220—024
20230—027
20240—078
20250—018
20260—0—

What is it indicated for?

The IMMAGE Immunochemistry System is a fully automated, computer controiled, bench-top chemistry analyzer intended for the in vitro quantitative measurement of therapeutic drugs and specific components of clinical use in biological fluids.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K922273

7 other devices cite the same predicate.

  • K994296Dimension C3 Flex Reagent CartridgeDade Behring, Inc. · 2000
  • K994293Dimension C4 Flex Reagent CartridgeDade Behring, Inc. · 2000
  • K994294Dimension TRNF Flex Reagent CartridgeDade Behring, Inc. · 2000
  • K994035Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000
  • K990551Igg Flex Reagent CartridgeDade Behring, Inc. · 1999
  • K990552Immunoglobulin a Test SystemDade Behring, Inc. · 1999

More from Beckman Instruments, Inc.

281 FDA decisions under this applicant name. See the company

  • K973448Access Toxoplasma Igm Reagents on the Access Immunoassay Analyzer, Models 34460, 34465, 34469Beckman Instruments, Inc. · 1998
  • K982250Access Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. · 19984 recalls
  • K981403Immage Immunochemistry System Valproic Acid (Vpa) ReagentBeckman Instruments, Inc. · 1998
  • K981354Access Afp Reagents on the Access Immunoassay Analyzer Model Number 33211Beckman Instruments, Inc. · 19981 recall
  • K980173Access Total BHCG Reagents on the Access Immunoassay Analyzer; 33500, 33505Beckman Instruments, Inc. · 19981 recall

Recent decisions in JQX

The JQX category page

  • K922273Array (R) 360Beckman Instruments, Inc. · 1992
  • K885263QMS (TM) - TheophyllineSeradyn, Inc. · 1989
  • K851253TDX Analyzer W/Nephelometry CarouselAbbott Laboratories · 1985
  • K851234A-Just Turbidity MeterAbbott Laboratories · 1985
  • K801362Albumin Nephelometric AssayJ.T. Baker Chemical Co. · 1980

https://510kreport.com/device/K962294 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962294: Immage Immunochemistry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962294

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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