510(k) · Cleared

Cleared

Cobas Integra Amikacin Mab

K991597510(k) TraditionalCleared Jul 22, 199973-day reviewClass II21 CFR 862.3035

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

Roche Diagnostics Corp. · LGJ Fluorescence Polarization Immunoassay, Amibacin

Cleared on Jul 22, 1999 as substantially equivalent to K954992 (Roche Diagnostic Systems, Inc., 1996) after a 73-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Jul 22, 1999
Review: 73 days
Class: Class II
Product code: LGJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954992 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954992 Roche Cobas Integra Reagent CassettesRoche Diagnostic Systems, Inc. · 1996
This deviceK991597 Cobas Integra Amikacin MabRoche Diagnostics Corp. · 1999
Descendant · cites it directly · 0 of its ownK032279 Online TDM AmikaRoche Diagnostics Corp. · 2003

Most influential descendants

Showing 1 of 1 · See all

K032279Online TDM AmikaRoche Diagnostics Corp. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954992	Roche Cobas Integra Reagent Cassettes	Roche Diagnostic Systems, Inc.	1996	—
0 (this device)	K991597	Cobas Integra Amikacin Mab	Roche Diagnostics Corp.	1999	—
+1	K032279	Online TDM Amika	Roche Diagnostics Corp.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K991597, 1996–2003Source: 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 LGJ? 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

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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
*	K954992	Roche Cobas Integra Reagent Cassettes Summary page 1 …name: Enzymatic assay for the determination of Amikacin Classification name: Amikacin test system We claim substantial equivalence to the Roche COBAS INTEGRA Amikacin (K954992). Continued on next page 24 510(k) Summary, Continued 4) Device description The Roche COBAS INTEGRA Amikacin…	Roche Diagnostic Systems, Inc.	1996	—

Also cleared against K954992: 6 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K032279	Online TDM Amika	Roche Diagnostics Corp.	2003	0

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, K032279 (Roche Diagnostics Corp., 2003) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K954992.

How does its category compare?

All LGJ devices

LGJ Fluorescence Polarization Immunoassay, Amibacin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LGJ

FDA has decided no LGJ device since 2007.

Median 510(k) review, days · LGJ

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

Recalls per year · LGJ

No recall names LGJ since 2007.

Adverse event reports per year · LGJ

No MAUDE report names LGJ since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The cassette COBAS INTEGRA Amikacin MAB contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of amikacin in human serum or heparinized plasma.

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/K991597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991597: Cobas Integra Amikacin Mab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991597

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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