510(k) · Cleared

Cleared

NG-Test® CTX-M MULTI

K243499510(k) TraditionalCleared Jun 4, 2025204-day reviewClass II21 CFR 866.1640

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

Ng Biotech · PTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Cleared on Jun 4, 2025 as substantially equivalent to K191889 (Ng Biotech, 2019) after a 204-day review. Its family tree reaches back 4 generations to 1985.

Decided: Jun 4, 2025
Review: 204 days
Class: Class II
Product code: PTJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K850291 (1985). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK850291 Mueller Hinton Agar W/4% Nacl W/AntibioticsRemel Co. · 1985 · Recalled
3 generations backK091766 Clearview Exact PBP2A Test, Model 891-000Binax, Inc. · 2010
2 generations backK162385 Rapidec Carba NPBiomerieux S.A. · 2017
1 generation backK191889 NG-Test CARBA 5Ng Biotech · 2019
This deviceK243499 NG-Test® CTX-M MULTINg Biotech · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K850291	Mueller Hinton Agar W/4% Nacl W/Antibiotics	Remel Co.	1985	2
−3	K091766	Clearview Exact PBP2A Test, Model 891-000	Binax, Inc.	2010	—
−2	K162385	Rapidec Carba NP	Biomerieux S.A.	2017	—
−1	K191889	NG-Test CARBA 5	Ng Biotech	2019	—
0 (this device)	K243499	NG-Test® CTX-M MULTI	Ng Biotech	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K243499, 1985–2025Source: 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 PTJ? 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
*	K191889	NG-Test CARBA 5 Summary page 5 …icrobial Susceptibility Test Powder Regulation Number: 21 CFR 866.1640 Regulatory Class: II Product Code: PTJ III. Predicate Device NG-Test CARBA 5 (K191889) IV. Device Description NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay f…	Ng Biotech	2019	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 40 years and passes through 4 companies; a new generation was cleared every 7.2 years on median.
1 of the 5 ancestors has a recall of any class.

How does its category compare?

All PTJ devices

PTJ Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · PTJ

1in 2025

2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PTJ

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

Recalls per year · PTJ

No recall names PTJ since 2007.

Adverse event reports per year · PTJ

8in 2021

2007high 8 (2021) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	2
2019	1	—	2
2020	0	—	2
2021	0	—	8
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

NG-Test® CTX-M MULTI is an in vitro rapid and visual immunochromatographic assay for the qualitative detection of CTX-M enzymes (groups 1, 2, 8, 9, and 25) from pure colonies of Enterobacterales suspected of ESBL production when grown on the following media: • 5% sheep blood agar or MacConkey agar (16-24 hours) • HardyCHROM™ ESBL agar (18-24 hours) The NG-Test® CTX-M MULTI is intended as an aid for infection control in the detection of CTX-M…

Read the full statement (130 words)

• 5% sheep blood agar or MacConkey agar (16-24 hours)

• HardyCHROM™ ESBL agar (18-24 hours)

The NG-Test® CTX-M MULTI is intended as an aid for infection control in the detection of CTX-M enzymes-producing organisms (Enterobacterales) in healthcare settings. NG-Test® CTX-M MULTI is not intended to guide or monitor treatment. A positive or negative NG- Test® CTX-M MULTI test result does not rule out the presence of other mechanisms of antibiotic resistance. NG-Test® CTX-M MULTI should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K243499 · printed Nov 5, 2026

Cite this page

510(k) Report. “K243499: NG-Test® CTX-M MULTI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243499

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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