510(k) Report

510(k) · Cleared

Cleared

Solid Phase Boil Dualcount (Dualcount SPB)

K860815510(k) TraditionalCleared Jul 11, 1986129-day reviewClass II21 CFR 862.1810

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

Diagnostic Products Corp. · CDD Radioassay, Vitamin B12

Cleared on Jul 11, 1986 after a 129-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 11, 1986
Review
129 days
Class
Class II
Product code
CDD
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1990200020102020
  1. This deviceK860815 Solid Phase Boil Dualcount (Dualcount SPB)Diagnostic Products Corp. · 1986
  2. Descendant · cites it directly · 0 of its ownK971177 Immulite Vitamin B12 (LKVB1,LKVB5)Diagnostic Products Corp. · 1997 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K971177Immulite Vitamin B12 (LKVB1,LKVB5)Diagnostic Products Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860815Solid Phase Boil Dualcount (Dualcount SPB)Diagnostic Products Corp.1986—
+1K971177Immulite Vitamin B12 (LKVB1,LKVB5)Diagnostic Products Corp.19971

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K860815, 1986–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 CDD? 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 CDD device

  1. #1 K233541 ARCHITECT Active-B12 (Holotranscobalamin)score 8.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K971177Immulite Vitamin B12 (LKVB1,LKVB5)Diagnostic 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, K971177 (Diagnostic Products Corp., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CDD devices

CDD Radioassay, Vitamin B12: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CDD

1in 2024

2007: 12009: 12010: 12011: 32012: 32013: 12014: 22015: 12016: 22017: 12019: 22022: 12024: 1
2007high 3 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CDD

147in 2012

2011: 117 days median2012: 147 days median
2007high 147 (2012) · low 117 (2011)2026

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

Recalls per year · CDD

1in 2021

2007: 12018: 22019: 12021: 1
2007high 2 (2018) · low 0 (2008)2026

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

Adverse event reports per year · CDD

44in 2025

2010: 42011: 362012: 232013: 452014: 122015: 42016: 62017: 92018: 152019: 142020: 112021: 282022: 242023: 272024: 332025: 44
2007high 45 (2013) · low 0 (2007)2025

MAUDE reports naming product code CDD, 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—10
20080—00
20091—00
20101—04
20113117036
20123147023
20131—045
20142—012
20151—04
20162—06
20171—09
20180—215
20192—114
20200—011
20210—128
20221—024
20230—027
20241—033
20250—044
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 CDD

The CDD category page

  • K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024
  • K223289Access Vitamin B12Beckman Coulter, Inc. · 2022
  • K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access…Beckman Coulter Biomedical GmbH · 20194 recalls
  • K192064LIAISON Vitamin B12DiaSorin, Inc. · 2019
  • K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. · 2017

https://510kreport.com/device/K860815 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860815: Solid Phase Boil Dualcount (Dualcount SPB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860815

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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