510(k) Report

510(k) · Cleared

Cleared

Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay

K981931510(k) TraditionalCleared Aug 25, 199884-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

Roche Diagnostics/Boehringer Mannheim GmbH · CGN Acid, Folic, Radioimmunoassay

Cleared on Aug 25, 1998 as substantially equivalent to K935286 (Bio-Rad, 1994) after an 84-day review. Its family tree reaches back 1 generation to 1994. 9 later devices descend from it.

Decided
Aug 25, 1998
Review
84 days
Class
Class II
Product code
CGN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K935286 (1994). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2024: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant clearedK935286 · Quantaphase II B12/Folate · Bio-Rad · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K935286 · Quantaphase II B12/Folate · Bio-Rad · 19940+5
  1. Root · 1 generation backK935286 Quantaphase II B12/FolateBio-Rad · 1994
  2. This deviceK981931 Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and…Roche Diagnostics/Boehringer Mannheim GmbH · 1998
  3. Descendant · cites it directly · 8 of its ownK051292 Elecsys RBC Folate Hemolyzed ReagentRoche Diagnostics Corp. · 2005
  4. Descendant · 2 generations on · 7 of its ownK082340 Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing…Roche Diagnostics Corp. · 2009
  5. Descendant · 3 generations on · 3 of its ownK111506 Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · Recalled
  6. Descendant · 4 generations on · 2 of its ownK132828 Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys…Roche Diagnostics · 2013
  7. Descendant · 3 generations on · 1 of its ownK103716 Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12011: 22013: 12014: 12018: 12024: 12026: 1
2005high 2 (2011) · low 0 (2006)2026

Most influential descendants

Showing 5 of 9 · See all
  • K051292Elecsys RBC Folate Hemolyzed ReagentRoche Diagnostics Corp. · 2005 · cites it directly8descendants
  • K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche Elecsys…Roche Diagnostics Corp. · 2009 · 2 generations on7descendants
  • K111506Elecsys Precicontrol Varia 3Roche Diagnostics · 2011 · 3 generations on3descendants
  • K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol Varia 3Roche Diagnostics · 2013 · 4 generations on2descendants
  • K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics · 2011 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935286Quantaphase II B12/FolateBio-Rad1994—
0 (this device)K981931Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys…Roche Diagnostics/Boehringer Mannheim GmbH1998—
+1K051292Elecsys RBC Folate Hemolyzed ReagentRoche Diagnostics Corp.2005—
+2K082340Roche Elecsys Folate Iii, Roche Elecsys RBC Folate Hemolysing Reagent, Roche…Roche Diagnostics Corp.2009—
+3K111506Elecsys Precicontrol Varia 3Roche Diagnostics20111
+4K132828Elecsys Calcitonin; Immunoassay, Calset, Calcheck 5; Elecsys Precicontrol…Roche Diagnostics2013—
+3K103716Roche Elecsys Folate RBC; Roche Elecsys Folate RBC CalsetRoche Diagnostics2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201120
201310
201410
201810
202410
202610
FIG. 1 — Lineage of K981931, 1994–2026Source: 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), 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 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? (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
*K935286Quantaphase II B12/Folate
Summary page 1
…f folate in human red blood cells. Classification name: Folate Test System. We claim substantial equivalence to the Bio-Rad Quantaphase II® FOLATE Radiobinding assay (K935286). The Elecsys® test principle is based on the competitive principle. Total duration of assay: 90 +- 15 minutes. e Reconstituti…
Bio-Rad1994—

Also cleared against K935286: 4 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K051292Elecsys RBC Folate Hemolyzed ReagentRoche Diagnostics Corp.20058

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?

  • Its one ancestor has no recall.
  • Of its descendants, K051292 (Roche Diagnostics Corp., 2005) has gone furthest, with 8 descendants of its own.
  • 4 other devices also cite its predicate K935286.

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—

What is it indicated for?

The Elecsys® Red Blood Cell Folate Lysing Reagent is to be used in combination with the Elecsys® Folate Assay for the quantitation of folate in human red blood cells.

The electrochemiluminescence assay “ECLIA” is intended for use on the Boehringer Mannheim Elecsys 2010 immunoassay analyzer.

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 K935286

4 other devices cite the same predicate.

  • K984166Vitros Immunodiagnostic Products Folate Reagent Pack 1/2, Vitros Immunodiagnostic Products Vitamin…Ortho-Clinical Diagnostics, Inc. · 19991 recall
  • K984321Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Anf CalibratorsOrtho-Clinical Diagnostics, Inc. · 19991 recall
  • K973702Elecsys Vitamin B12 AssayBoehringer Mannheim Corp. · 1997
  • K973674Elecsys FolateBoehringer Mannheim Corp. · 1997

More from Roche Diagnostics/Boehringer Mannheim…

3 FDA decisions under this applicant name. See the company

  • K983892Coaguchek Pro System, Aptt Test Cartridges for Coaguchek Pro System, Aptt Controls for Coaguchek Pro System…Roche Diagnostics/Boehringer Mannheim GmbH · 19991 recall
  • K981632Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin ReagentRoche Diagnostics/Boehringer Mannheim GmbH · 1998

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/K981931 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981931

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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