510(k) Report

510(k) · Cleared

Cleared

Holotc Ria

K030655510(k) TraditionalCleared Jan 29, 2004332-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

Axis-Shield Biochemicals, Asa · CDD Radioassay, Vitamin B12

Cleared on Jan 29, 2004 as substantially equivalent to K993571 (Bayer Corp., 1999) after a 332-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it.

Decided
Jan 29, 2004
Review
332 days
Class
Class II
Product code
CDD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993571 (1999). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2011: 1 descendant cleared2016: 1 descendant cleared2024: 1 descendant cleared2013: 1 descendant cleared2017: 1 descendant clearedK993571 · Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12 · Bayer Corp. · 19991995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 1 descendant K993571 · Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12 · Bayer Corp. · 19990
  1. Root · 1 generation backK993571 Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12Bayer Corp. · 1999
  2. This deviceK030655 Holotc RiaAxis-Shield Biochemicals, Asa · 2004
  3. Descendant · cites it directly · 5 of its ownK062467 Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit…Axis-Shield Diagnostics, Ltd. · 2006
  4. Descendant · 2 generations on · 4 of its ownK112443 Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011
  5. Descendant · 3 generations on · 1 of its ownK160757 ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA…Axis-Shield Diagnostics Limited · 2016
  6. Descendant · 3 generations on · 0 of its ownK233541 ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024
  7. Descendant · 4 generations on · 0 of its ownK172133 ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. · 2017

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2006: 12011: 12013: 12016: 12017: 12024: 1
2006high 1 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K062467Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01…Axis-Shield Diagnostics, Ltd. · 2006 · cites it directly5descendants
  • K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2011 · 2 generations on4descendants
  • K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited · 2016 · 3 generations on1descendant
  • K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd. · 2024 · 3 generations on0descendants
  • K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd. · 2017 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993571Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12Bayer Corp.1999—
0 (this device)K030655Holotc RiaAxis-Shield Biochemicals, Asa2004—
+1K062467Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model…Axis-Shield Diagnostics, Ltd.2006—
+2K112443Architect Active B-12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.2011—
+3K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur…Axis-Shield Diagnostics Limited2016—
+3K233541ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.2024—
+4K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayAxis-Shield Diagnostics, Ltd.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201110
201310
201610
201710
202410
FIG. 1 — Lineage of K030655, 1999–2024Source: 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 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? (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
*K993571Bayer Diagnostics Acs:180 VB12, Bayer Diagnostics Advia Centaue VB12
Summary page 1
…( 57 Co) as opposed to chemiluminescence in the predicate device. Method Comparison The Axis-Shield HoloTC RIA was compared to the Bayer Advia Centaur VB12 assay (K993571) using 392 patient samples with vitamin B12 concentrations ranging from 114- 821 pmol/L. Linear regression (least squares) yielde…
Bayer Corp.1999—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K062467Axsym Holo TC Reagent Kit, Model 3L83-20; Standard Calibrator Kit, Model 3L83-01…Axis-Shield Diagnostics, Ltd.20065

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, K062467 (Axis-Shield Diagnostics, Ltd., 2006) has gone furthest, with 5 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—

What is it indicated for?

The Axis-Shield HoloTC RIA is an in-vitro diagnostic assay for quantitative measurement of the fraction of cobalamin (vitamin B12) bound to the carrier protein transcobalamin in human serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin B12 deficiency.

Indications for use as stated in the FDA summary.

More from Axis-Shield Biochemicals, Asa

2 FDA decisions under this applicant name. See the company

  • K001651Bio-Rad %CDT TiaAxis-Shield Biochemicals, Asa · 2000

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/K030655 · printed Nov 4, 2026

Cite this page

510(k) Report. “K030655: Holotc Ria.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030655

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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