510(k) · Cleared

Recalled · 2011

Access Ostase QC

K994277510(k) TraditionalCleared Jan 14, 200025-day reviewClass I21 CFR 862.1660Recalls 2

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

Beckman Coulter, Inc. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

Cleared on Jan 14, 2000 as substantially equivalent to K981864 (Beckman Coulter, Inc., 1998) after a 25-day review. Its family tree reaches back 2 generations to 1989. It has been recalled 2 times.

Decided: Jan 14, 2000
Review: 25 days
Class: Class I
Product code: JJX
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K891475 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK891475 Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3Bio-Rad · 1989
1 generation backK981864 Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219Beckman Coulter, Inc. · 1998 · Recalled
This deviceK994277 Access Ostase QCBeckman Coulter, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K891475	Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3	Bio-Rad	1989	—
−1	K981864	Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219	Beckman Coulter, Inc.	1998	1
0 (this device)	K994277	Access Ostase QC	Beckman Coulter, Inc.	2000	—

FIG. 1 — Lineage of K994277, 1989–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K981864	Access Afp QC on the Access Immunoassay Analyzer, Model Number 33219 Summary page 1 …cation Class \| (low risk) 40 Predicate Device(s): BECKMAN Predicate \| Predicate Company \| Docket COULTER Reagent Number Access Ostase QC Access Beckman Coulter Inc. \| K981864 AFP QC Beckman Coulter Inc., Section 510(k) Notification Section1 Page14 Access® Ostase® QC AccessOstaseQC/Ostase510(k)sec1.doc…	Beckman Coulter, Inc.	1998	1

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2011	Not classified	Z-1239-2012	Process design	The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access…
May 10, 2011	Not classified	Z-2606-2011	Package design/selection	The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers.…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All JJX devices

JJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJX

2in 2017

2007high 24 (2010) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJX

31in 2016

2007high 80 (2009) · low 30 (2014)2026

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

Recalls per year · JJX

1in 2021

2007high 3 (2007) · low 0 (2009)2026

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

Adverse event reports per year · JJX

22in 2025

2007high 82 (2019) · low 0 (2008)2025

MAUDE reports naming product code JJX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	53	3	2
2008	8	52	3	0
2009	17	80	0	1
2010	24	80	3	6
2011	19	62	2	62
2012	15	40	0	32
2013	19	37	0	51
2014	22	30	1	48
2015	11	65	1	67
2016	6	31	2	37
2017	2	—	0	19
2018	0	—	2	35
2019	0	—	0	82
2020	0	—	0	77
2021	0	—	1	43
2022	0	—	0	24
2023	0	—	0	22
2024	0	—	0	30
2025	0	—	0	22
2026	0	—	0	—

What is it indicated for?

Beckman Coulter’s Access Ostase QC is intended for use in monitoring the

reliability and overall performance of the Access Ostase Immunoassay system

in the clinical laboratory. The use of control materials allow the laboratorian to

monitor linearity along with analytical error and imprecision.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K994277 · printed Nov 5, 2026

Cite this page

510(k) Report. “K994277: Access Ostase QC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994277

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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