510(k) Report

510(k) · Cleared

Cleared

Alastat Allergen Specified Ige System, Modified

K911511510(k) TraditionalCleared Apr 17, 199113-day reviewClass II21 CFR 866.5510

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

Diagnostic Products Corp. · DGO Ige, Peroxidase, Antigen, Antiserum, Control

Cleared on Apr 17, 1991 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided
Apr 17, 1991
Review
13 days
Class
Class II
Product code
DGO
Recalls
None
Predicates
0

13 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 2 descendants cleared1997: 1 descendant cleared2009: 5 descendants cleared2011: 2 descendants cleared2026: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK911511 Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp. · 1991
  2. Descendant · cites it directly · 10 of its ownK013134 Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel…Diagnostic Products Corp. · 2001 · Recalled
  3. Descendant · cites it directly · 8 of its ownK013135 Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels…Diagnostic Products Corp. · 2001
  4. Descendant · 2 generations on · 2 of its ownK101572 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics · 2011 · Recalled
  5. Descendant · 2 generations on · 2 of its ownK093987 Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc. · 2011
  6. Descendant · 3 generations on · 1 of its ownK112523 Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc. · 2012

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997: 12001: 22009: 52011: 22012: 12014: 12026: 1
1997high 5 (2009) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · See all
  • K013134Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)Diagnostic Products Corp. · 2001 · cites it directly10descendants
  • K013135Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)Diagnostic Products Corp. · 2001 · cites it directly8descendants
  • K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics · 2011 · 2 generations on2descendants
  • K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc. · 2011 · 2 generations on2descendants
  • K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc. · 2012 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911511Alastat Allergen Specified Ige System, ModifiedDiagnostic Products Corp.1991—
+1K013134Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600…Diagnostic Products Corp.20012
+1K013135Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6…Diagnostic Products Corp.2001—
+2K101572Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics20114
+2K093987Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6Siemens Healthcare Diagnostics, Inc.2011—
+3K112523Immulite 2000 3GALLERGY Specific Ige Assay KitSiemens Healthcare Diagnostics, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200120
200950
201120
201210
201410
202610
FIG. 1 — Lineage of K911511, 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DGO? 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K013134Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests)Diagnostic Products Corp.200110
K013135Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests)Diagnostic Products Corp.20018
K973186Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific IgeDiagnostic Products Corp.19970

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?

  • Of its descendants, K013134 (Diagnostic Products Corp., 2001) has gone furthest, with 10 descendants of its own.

How does its category compare?

All DGO devices

DGO Ige, Peroxidase, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DGO

FDA has decided no DGO device since 2007.

Median 510(k) review, days · DGO

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

Recalls per year · DGO

No recall names DGO since 2007.

Adverse event reports per year · DGO

No MAUDE report names DGO since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

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 DGO

The DGO category page

  • K943194Immulite (R) Allergy Food Panel FP5EDiagnostic Products Corp. · 1995
  • K920087Ige Eia Test KitThe Binding Site, Ltd. · 1992
  • K894039Quidel Total Ige Test Quantitative VersionQuidel Corp. · 1989
  • K893125Beckman Epsilon (TM) Ige Reagent KitBeckman Instruments, Inc. · 1989
  • K872801Alleia Total Ige Eia W/Mono Anti. EKIE1, 2, 5Diagnostic Products Corp. · 1987

https://510kreport.com/device/K911511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911511: Alastat Allergen Specified Ige System, Modified.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911511

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026