510(k) Report

510(k) · Cleared

Recalled · Class II · 2025

Immulite 2000 Specific Allergens

K021206510(k) TraditionalCleared May 30, 200244-day reviewClass II21 CFR 866.5750Recalls 1

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

Diagnostic Products Corp. · DHB System, Test, Radioallergosorbent (Rast) Immunological

Cleared on May 30, 2002 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled once.

Decided
May 30, 2002
Review
44 days
Class
Class II
Product code
DHB
Recalls
1
Predicates
0

10 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2009: 5 descendants cleared2011: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared200020052010201520202025
  1. This deviceK021206 Immulite 2000 Specific AllergensDiagnostic Products Corp. · 2002
  2. Descendant · cites it directly · 2 of its ownK101572 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics · 2011 · Recalled
  3. Descendant · cites it directly · 2 of its ownK100910 Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2011
  4. Descendant · cites it directly · 2 of its ownK093987 Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc. · 2011
  5. Descendant · 2 generations on · 1 of its ownK112523 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc. · 2012
  6. Descendant · 3 generations on · 0 of its ownK132801 Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc. · 2014

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009: 52011: 32012: 12014: 1
2009high 5 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 10 · See all
  • K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics · 2011 · cites it directly2descendants
  • K100910Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics · 2011 · cites it directly2descendants
  • K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc. · 2011 · cites it directly2descendants
  • K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on1descendant
  • K132801Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021206Immulite 2000 Specific AllergensDiagnostic Products Corp.2002—
+1K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20114
+1K100910Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics2011—
+1K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc.2011—
+2K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc.2012—
+3K132801Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200950
201130
201210
201410
FIG. 1 — Lineage of K021206, 2002–2014Source: 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 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 DHB? 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 DHB device

  1. #1 K260331 IMMULITE 2000 3gAllergy Specific IgE Vantage…score 12.3 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (10)

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20112
K100910Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics20112
K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc.20112
K091984Immulite 2000 3GALLERGY Specific Ige Assay Kit, Model L2KUN6Siemens Medical Solutions Diagnostics20090
K091289Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090
K090257Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090
K083853Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090
K083314Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20090

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 6, 2025Class IIZ-0491-2026Under Investigation by firmThe barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K101572 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DHB devices

DHB System, Test, Radioallergosorbent (Rast) Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DHB

2in 2025

2007: 12008: 22009: 72010: 32011: 52012: 32013: 52014: 12015: 12016: 22017: 12018: 22019: 32020: 22021: 12022: 22025: 22026 (partial year): 6
2007high 7 (2009) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DHB

90in 2019

2009: 118 days median2010: 247 days median2011: 405 days median2012: 260 days median2013: 257 days median2019: 90 days median2026 (partial year): 138 days median
2007high 405 (2011) · low 90 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DHB

14in 2025

2012: 12014: 12017: 12018: 12022: 32025: 14
2007high 14 (2025) · low 0 (2007)2026

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

Adverse event reports per year · DHB

6in 2025

2008: 12011: 12012: 22015: 12017: 112018: 62019: 42021: 72022: 12023: 62024: 102025: 6
2007high 11 (2017) · low 0 (2007)2025

MAUDE reports naming product code DHB, 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
20071—00
20082—01
2009711800
2010324700
2011540501
2012326012
2013525700
20141—10
20151—01
20162—00
20171—111
20182—16
201939004
20202—00
20211—07
20222—31
20230—06
20240—010
20252—146
202661380—

What is it indicated for?

The IMMULITE® 2000 Allergen-Specific IgE and specific allergens are for in vitro diagnostic use with the IMMULITE® 2000 Analyzer — for the measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE—mediated allergic disorders.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Diagnostic Products Corp.

321 FDA decisions under this applicant name. See the company

  • K063045Immulite 2000, Immulite 2500 VancomycinDiagnostic Products Corp. · 2006
  • K034055Immulite 2500 CK-MB, 2500 Myoglobin, 2500 Stat Troponin IDiagnostic Products Corp. · 20041 recall
  • K033234Immulite 2500 Automated Immunoassay AnalyzerDiagnostic Products Corp. · 20033 recalls
  • K032881Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneDiagnostic Products Corp. · 20032 recalls
  • K023152Immulite 2000 Allergen-Specific IgeDiagnostic Products Corp. · 2002

Recent decisions in DHB

The DHB category page

  • K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd. · 2026
  • K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut…Hycor Biomedical · 2026
  • K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond…Hycor Biomedical · 2026
  • K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab…Hycor Biomedical · 2026
  • K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036…Hycor Biomedical · 2026

https://510kreport.com/device/K021206 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021206: Immulite 2000 Specific Allergens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021206

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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