510(k) · Cleared

Recalled · Class II · 2013

Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772

K991834510(k) TraditionalCleared Sep 9, 1999104-day reviewClass I21 CFR 862.1030Recalls 1

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

Cholestech Corp. · CKD Hydrazone Colorimetry, Alt/Sgpt

Cleared on Sep 9, 1999 as substantially equivalent to K864082 (Boehringer Mannheim Corp., 1986) after a 104-day review. Its family tree reaches back 1 generation to 1986. It has been recalled once.

Decided: Sep 9, 1999
Review: 104 days
Class: Class I
Product code: CKD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K864082 (1986). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK864082 Reflotron (R) Alt (GPT)Boehringer Mannheim Corp. · 1986 · Recalled
This deviceK991834 Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772Cholestech Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K864082	Reflotron (R) Alt (GPT)	Boehringer Mannheim Corp.	1986	1
0 (this device)	K991834	Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772	Cholestech Corp.	1999	—

FIG. 1 — Lineage of K991834, 1986–1999Source: 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 CKD? 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
*	K864082	Reflotron (R) Alt (GPT) Summary page 2 …ts in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Roche Diagnostics Reflotron GPT (ALT) test (K864082). Continued on next page page 24 Cholestech Corporation L-D-X ALT 510(k) Summary, Continued 6. Comparison to…	Boehringer Mannheim Corp.	1986	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
Mar 6, 2013	Class II	Z-1139-2013	Other	The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.

How does its category compare?

All CKD devices

CKD Hydrazone Colorimetry, Alt/Sgpt: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CKD

FDA has decided no CKD device since 2007.

Median 510(k) review, days · CKD

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

Recalls per year · CKD

No recall names CKD since 2007.

Adverse event reports per year · CKD

No MAUDE report names CKD 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 Cholestech L-D-X Alanine aminotransferase Test (ALT) is for the in vitro quantitative determination of alanine aminotransferase (ALT) in whole blood or serum on the Cholestech L-D-X Analyzer.

Alanine aminotransferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

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/K991834 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991834: Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991834

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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