510(k) Report

510(k) · Cleared

Cleared

Quantaphase II B12/Folate

K935286510(k) TraditionalCleared Feb 18, 1994137-day reviewClass II21 CFR 862.1295

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

Bio-Rad · CGN Acid, Folic, Radioimmunoassay

Cleared on Feb 18, 1994 after a 137-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 26 later devices descend from it.

Decided
Feb 18, 1994
Review
137 days
Class
Class II
Product code
CGN
Recalls
None
Predicates
0

26 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1997: 2 descendants cleared1998: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared2005: 1 descendant cleared2004: 1 descendant cleared2009: 1 descendant cleared2011: 3 descendants cleared2014: 3 descendants cleared2012: 2 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2024: 1 descendant cleared2013: 1 descendant cleared2019: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK935286 Quantaphase II B12/FolateBio-Rad · 1994
  2. Descendant · cites it directly · 10 of its ownK973702 Elecsys Vitamin B12 AssayBoehringer Mannheim Corp. · 1997
  3. Descendant · cites it directly · 10 of its ownK973674 Elecsys FolateBoehringer Mannheim Corp. · 1997
  4. Descendant · 2 generations on · 9 of its ownK060755 Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006
  5. Descendant · 2 generations on · 9 of its ownK031756 Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp. · 2003
  6. Descendant · cites it directly · 9 of its ownK981931 Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and…Roche Diagnostics/Boehringer Mannheim GmbH · 1998

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

1997: 21998: 11999: 22003: 12004: 12005: 12006: 12009: 12011: 32012: 22013: 12014: 32015: 12016: 12018: 12019: 22024: 12026: 1
1997high 3 (2011) · low 0 (2000)2026

Most influential descendants

Showing 5 of 26 · See all
  • K973702Elecsys Vitamin B12 AssayBoehringer Mannheim Corp. · 1997 · cites it directly10descendants
  • K973674Elecsys FolateBoehringer Mannheim Corp. · 1997 · cites it directly10descendants
  • K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp. · 2006 · 2 generations on9descendants
  • K031756Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp. · 2003 · 2 generations on9descendants
  • K981931Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate AssayRoche Diagnostics/Boehringer Mannheim GmbH · 1998 · cites it directly9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935286Quantaphase II B12/FolateBio-Rad1994—
+1K973702Elecsys Vitamin B12 AssayBoehringer Mannheim Corp.1997—
+1K973674Elecsys FolateBoehringer Mannheim Corp.1997—
+2K060755Elecsys Vitamin B12 Immunoassay, Calset II and CalcheckRoche Diagnostics Corp.2006—
+2K031756Roche Diagnostics Elecsys Folate II AssayRoche Diagnostics Corp.2003—
+1K981931Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys…Roche Diagnostics/Boehringer Mannheim GmbH1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
199920
200310
200410
200510
200610
200910
201130
201220
201310
201430
201510
201610
201810
201920
202410
202610
FIG. 1 — Lineage of K935286, 1994–2026Source: 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 CGN? 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 CGN device

  1. #1 K233060 Elecsys Folate IIIscore 9.9 · 9 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K973702Elecsys Vitamin B12 AssayBoehringer Mannheim Corp.199710
K973674Elecsys FolateBoehringer Mannheim Corp.199710
K981931Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate AssayRoche Diagnostics/Boehringer Mannheim GmbH19989
K984166Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic…Ortho-Clinical Diagnostics, Inc.19990
K984321Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3…Ortho-Clinical Diagnostics, Inc.19990

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, K973702 (Boehringer Mannheim Corp., 1997) has gone furthest, with 10 descendants of its own.

How does its category compare?

All CGN devices

CGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGN

1in 2024

2009: 22010: 12011: 12014: 12016: 12018: 12020: 12023: 12024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGN

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

Recalls per year · CGN

3in 2019

2007: 22008: 12009: 12010: 12012: 22013: 12018: 22019: 3
2007high 3 (2019) · low 0 (2011)2026

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

Adverse event reports per year · CGN

9in 2025

2007: 262009: 32011: 282012: 112013: 22014: 42015: 12016: 42017: 62018: 22019: 12020: 52021: 32022: 132023: 82024: 192025: 9
2007high 28 (2011) · low 0 (2008)2025

MAUDE reports naming product code CGN, 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
20070—226
20080—10
20092—13
20101—10
20111—028
20120—211
20130—12
20141—04
20150—01
20161—04
20170—06
20181—22
20190—31
20201—05
20210—03
20220—013
20231—08
20241—019
20250—09
20260—0—

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Recent decisions in CGN

The CGN category page

  • K233060Elecsys Folate IIIRoche Diagnostics · 2024
  • K223590Access Folate AssayBeckman Coulter, Inc. · 2023
  • K192586LIAISON® FolateDiaSorin, Inc. · 2020
  • K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. · 20183 recalls
  • K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme Laboratories · 2016

https://510kreport.com/device/K935286 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935286: Quantaphase II B12/Folate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935286

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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