510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Aia-Pack Brca, ST Aia Pack Brca

K010796510(k) TraditionalCleared Aug 16, 2001153-day reviewClass II21 CFR 866.6010Recalls 1

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

Tosoh Medics, Inc. · MOI System, Test, Immunological, Antigen, Tumor

Cleared on Aug 16, 2001 after a 153-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Aug 16, 2001
Review
153 days
Class
Class II
Product code
MOI
Recalls
1
Predicates
0

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

Descendants, by year cleared 2009: 1 descendant cleared200020052010201520202025
  1. This deviceK010796 Aia-Pack Brca, ST Aia Pack BrcaTosoh Medics, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK080469 Vidas CA 15-3 AssaybioMerieux, Inc. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K080469Vidas CA 15-3 AssaybioMerieux, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010796Aia-Pack Brca, ST Aia Pack BrcaTosoh Medics, Inc.2001—
+1K080469Vidas CA 15-3 AssaybioMerieux, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K010796, 2001–2009Source: 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 MOI? 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 MOI device

  1. #1 K240403 Access BR Monitorscore 7.9 · 3 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K080469Vidas CA 15-3 AssaybioMerieux, Inc.20090

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 5, 2018Class IIZ-2070-2018Device DesignAsfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K080469 (bioMerieux, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MOI devices

MOI System, Test, Immunological, Antigen, Tumor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOI

2in 2024

2007: 12011: 12018: 22019: 12020: 22024: 2
2007high 2 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOI

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

Recalls per year · MOI

2in 2012

2007: 12012: 2
2007high 2 (2012) · low 0 (2008)2026

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

Adverse event reports per year · MOI

6in 2025

2007: 22008: 32009: 32010: 222011: 32012: 42013: 32014: 522015: 282016: 52017: 72018: 12019: 52020: 112021: 162022: 162023: 62024: 52025: 6
2007high 52 (2014) · low 1 (2018)2025

MAUDE reports naming product code MOI, 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—12
20080—03
20090—03
20100—022
20111—03
20120—24
20130—03
20140—052
20150—028
20160—05
20170—07
20182—01
20191—05
20202—011
20210—016
20220—016
20230—06
20242—05
20250—06
20260—0—

More from Tosoh Medics, Inc.

41 FDA decisions under this applicant name. See the company

  • K023893ST Aia-Pack Cea Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023894ST Aia-Pack Afp Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023091ST Aia-Pack Testosterone AssayTosoh Medics, Inc. · 20023 recalls
  • K023891ST Aia-Pack CA 125 Enzyme ImmunoassayTosoh Medics, Inc. · 2002
  • K020489G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc. · 20022 recalls

Recent decisions in MOI

The MOI category page

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  • K192777ADVIA Centaur CA 15-3 assaySiemens Healthcare Diagnostics, Inc. · 2019

https://510kreport.com/device/K010796 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010796: Aia-Pack Brca, ST Aia Pack Brca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010796

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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