510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Modification to: Unicap Specific Ige

K051218510(k) SpecialCleared Jun 9, 200528-day reviewClass II21 CFR 866.5750Recalls 3

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

Pharmacia Diagnostics AB · DHB System, Test, Radioallergosorbent (Rast) Immunological

Cleared on Jun 9, 2005 as substantially equivalent to K962274 (Pharmacia, Inc., 1996) after a 28-day review. Its family tree reaches back 1 generation to 1996. 30 later devices descend from it. It has been recalled 3 times.

Decided
Jun 9, 2005
Review
28 days
Class
Class II
Product code
DHB
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K962274 (1996). 30 later devices descend from it, 27 citing it directly.

Descendants, by year cleared 2013: 3 descendants cleared2007: 1 descendant cleared2018: 2 descendants cleared2020: 2 descendants cleared2011: 2 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared2009: 1 descendant cleared2019: 2 descendants cleared2012: 1 descendant cleared2026: 5 descendants cleared2025: 2 descendants cleared2010: 1 descendant cleared2016: 3 descendants cleared2022: 2 descendants cleared2024: 1 descendant clearedK962274 · Unicap 100 · Pharmacia, Inc. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 27 descendants2 generations forward: 3 descendants K962274 · Unicap 100 · Pharmacia, Inc. · 19960
  1. Root · 1 generation backK962274 Unicap 100Pharmacia, Inc. · 1996
  2. This deviceK051218 Modification to: Unicap Specific IgePharmacia Diagnostics AB · 2005
  3. Descendant · cites it directly · 1 of its ownK161899 ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip…Phadia AB · 2016 · Recalled
  4. Descendant · cites it directly · 1 of its ownK113841 Immunocap Allergen Components BundlePhadia US, Inc. · 2012
  5. Descendant · cites it directly · 1 of its ownK101251 Immunocap Allergen D202, Allergen Component Nder P 1, House Dust…Phadia AB · 2011
  6. Descendant · cites it directly · 0 of its ownK261027 NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine…Hycor Biomedical · 2026
  7. Descendant · cites it directly · 0 of its ownK260591 NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed…Hycor Biomedical · 2026

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12011: 22012: 12013: 32015: 12016: 32017: 12018: 22019: 22020: 22022: 22024: 12025: 22026: 5
2007high 5 (2026) · low 0 (2008)2026

Most influential descendants

Showing 5 of 30 · See all
  • K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB · 2016 · cites it directly1descendant
  • K113841Immunocap Allergen Components BundlePhadia US, Inc. · 2012 · cites it directly1descendant
  • K101251Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap…Phadia AB · 2011 · cites it directly1descendant
  • K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…Hycor Biomedical · 2026 · cites it directly0descendants
  • K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…Hycor Biomedical · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962274Unicap 100Pharmacia, Inc.1996—
0 (this device)K051218Modification to: Unicap Specific IgePharmacia Diagnostics AB2005—
+1K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP…Phadia AB20161
+1K113841Immunocap Allergen Components BundlePhadia US, Inc.2012—
+1K101251Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite…Phadia AB2011—
+1K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max)…Hycor Biomedical2026—
+1K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum…Hycor Biomedical2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201120
201210
201330
201510
201630
201710
201820
201920
202020
202220
202410
202520
202650
FIG. 1 — Lineage of K051218, 1996–2026Source: 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
*K962274Unicap 100
Summary page 1
…UniCAP Specific IgE 82DHB II 866.5750 Substantial Equivalence to: UniCAP Specific IgE (K962274) Pharmacia Diagnostics AB Premarket Notification Special 510(k): Device Modification Page 13 of 16 Pharmacia…
Pharmacia, Inc.1996—

Also cleared against K962274: 16 other devices →

What descends from it? (30)

See all 30

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

NumberDeviceApplicantDecidedDescendants
K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE…Phadia AB20161
K113841Immunocap Allergen Components BundlePhadia US, Inc.20121
K101251Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap…Phadia AB20111
K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent…Hycor Biomedical20260
K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture…Hycor Biomedical20260
K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture…Hycor Biomedical20260
K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa)…Hycor Biomedical20260
K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture…Hycor Biomedical20260
K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent…Hycor Biomedical20250
K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum…Hycor Biomedical20250

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 9, 2019Class IIZ-2397-2019Under Investigation by firmcode 7-102 Liquid Sensor Error
Dec 18, 2017Class IIZ-1312-2018Device DesignThe stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.
Dec 18, 2017Class IIZ-1313-2018Device DesignThe stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K161899 (Phadia AB, 2016) has gone furthest, with 1 descendant of its own.
  • 16 other devices also cite its predicate K962274.

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?

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE is to be used with the instrument ImmunoCAP/UniCAP 250 and ImmunoCAP/UniCAP 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. The UniCAP Specific IgE is…

Read the full statement (145 words)

UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE is to be used with the instrument ImmunoCAP/UniCAP 250 and ImmunoCAP/UniCAP 1000. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories.

The UniCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE is to be used with the instrument ImmunoCAP 100/UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.

Indications for use as stated in the FDA summary.

Also cleared against K962274

16 other devices cite the same predicate.

  • K190315ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f…Phadia AB · 2019
  • K173726ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, PeanutPhadia AB · 2018
  • K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgEPhadia AB · 2017
  • K150854ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP…Phadia AB · 2015
  • K122197Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige AntibodiesPhadia US, Inc. · 20131 recall
  • K123275IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOMPhadia AB · 20131 recall

More from Pharmacia Diagnostics AB

2 FDA decisions under this applicant name. See the company

  • K052793Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02Pharmacia Diagnostics AB · 2006

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/K051218 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051218: Modification to: Unicap Specific Ige.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051218

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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