510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)

K013134510(k) SpecialCleared Oct 15, 200126-day reviewClass II21 CFR 866.5750Recalls 2

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 Oct 15, 2001 as substantially equivalent to K911511 (Diagnostic Products Corp., 1991) after a 26-day review. Its family tree reaches back 1 generation to 1991. 10 later devices descend from it. It has been recalled 2 times.

Decided
Oct 15, 2001
Review
26 days
Class
Class II
Product code
DHB
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K911511 (1991). 10 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2009: 5 descendants cleared2011: 2 descendants cleared2026: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant clearedK911511 · Alastat Allergen Specified Ige System, Modified · Diagnostic Products Corp. · 19911990200020102020
Descendants, by generation 1 generation forward: 8 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K911511 · Alastat Allergen Specified Ige System, Modified · Diagnostic Products Corp. · 19910
  1. Root · 1 generation backK911511 Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp. · 1991
  2. This deviceK013134 Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel…Diagnostic Products Corp. · 2001
  3. Descendant · cites it directly · 2 of its ownK101572 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics · 2011 · Recalled
  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 · cites it directly · 0 of its ownK260331 IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems…Siemens Healthcare Diagnostics Products, Ltd. · 2026
  7. 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: 22012: 12014: 12026: 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
  • 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
  • K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd. · 2026 · cites it directly0descendants
  • 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
−1K911511Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp.1991—
0 (this device)K013134Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600…Diagnostic Products Corp.2001—
+1K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20114
+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—
+1K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut…Siemens Healthcare Diagnostics Products, Ltd.2026—
+3K132801Immulite 2000 Systems 3GALLERGY Specific Ige AssaySiemens Healthcare Diagnostics, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200950
201120
201210
201410
202610
FIG. 1 — Lineage of K013134, 1991–2026Source: 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 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K911511Alastat Allergen Specified Ige System, Modified
Summary page 1
…CA 90045-5597 Establishment ) Registration #: DPC Registration number is 2017183 Substantially Equivalent AlaSTAT® Microplate Allergen-Specific Predicate Device: IgE (K911511) 13 Description of Device: IMMULITE 2000 Allergen-Specific IgE is for in vitro diagnostic use with the IMMULITE…
Diagnostic Products Corp.1991—

Also cleared against K911511: 2 other devices →

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
K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc.20112
K260331IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13)Siemens Healthcare Diagnostics Products, Ltd.20260
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
Jan 2, 2018Class IIZ-1674-2018Error in labelingConcentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the…
May 6, 2015Class IIZ-1843-2015Under Investigation by firmIMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and 208, fail to meet specifications to support the shelf-life stability of 2 years (24 months) expiration date as indicated on the products label.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K101572 (Siemens Healthcare Diagnostics, 2011) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K911511.

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 is 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 summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K911511

2 other devices cite the same predicate.

  • K013135Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)Diagnostic Products Corp. · 2001
  • K973186Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific IgeDiagnostic Products Corp. · 1997

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/K013134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K013134: Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013134

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026