510(k) · Cleared

Cleared

Dried Gram-Negative and Gram-Positive Mic/Combo Panels

K983408510(k) TraditionalCleared May 10, 1999224-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

Dade Microscan, Inc. · JWY Manual Antimicrobial Susceptibility Test Systems

Cleared on May 10, 1999 after a 224-day review. The FDA summary names its predicate without a number. 1 later device descends from it.

Decided: May 10, 1999
Review: 224 days
Class: Class II
Product code: JWY
Recalls: None
Predicates: 0

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

This deviceK983408 Dried Gram-Negative and Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 1999
Descendant · cites it directly · 0 of its ownK993102 Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K993102Dried Gram-Positive Mic/Combo PanelsDade Microscan, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K983408	Dried Gram-Negative and Gram-Positive Mic/Combo Panels	Dade Microscan, Inc.	1999	—
+1	K993102	Dried Gram-Positive Mic/Combo Panels	Dade Microscan, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K983408, 1999–1999Source: 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 JWY? 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 JWY device

#1 K260447 ETEST Gepotidacin (GEP) (0.016-256 µg/mL)score 12.7 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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
*	—	NCCLS Frozen Trovafloxacin Reference Panels Named without a submission number			—

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
K993102	Dried Gram-Positive Mic/Combo Panels	Dade Microscan, Inc.	1999	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?

Of its descendants, K993102 (Dade Microscan, Inc., 1999) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JWY devices

JWY Manual Antimicrobial Susceptibility Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JWY

14in 2025

2007high 18 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWY

106in 2025

2007high 266 (2021) · low 51 (2018)2026

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

Recalls per year · JWY

31in 2022

2007high 31 (2022) · low 0 (2007)2026

Class I (13 since 2007) Class II/III not classified

Adverse event reports per year · JWY

1in 2024

2007high 41 (2021) · low 0 (2007)2025

MAUDE reports naming product code JWY, 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	0	—	0	0
2008	6	85	1	1
2009	2	—	0	1
2010	4	73	0	0
2011	4	125	3	0
2012	1	—	0	0
2013	0	—	0	0
2014	6	106	5	4
2015	9	90	6 (4)	11
2016	4	88	0	20
2017	14	61	2	9
2018	12	51	0	13
2019	18	60	0	10
2020	5	66	0	20
2021	5	266	0	41
2022	0	—	31 (9)	11
2023	7	85	0	9
2024	6	90	0	1
2025	14	106	0	0
2026	2	—	0	—

What is it indicated for?

To determine gram-negative and gram-positive bacterial susceptibility against the antimicrobial agent Trovafloxacin. Organisms with indications for testing* include: Gram-Negative Bacteria Gram-Positive Bacteria Escherichia coli Methicillin susceptible Klebsiella pneumoniae Staphylococcus aureus Proteus mirabilis Methicillin susceptible Pseudomonas aeruginosa Staphylococcus epidermidis Enterococcus faecalis Streptococcus agalactiae (Gp.B) Streptococcus…

Read the full statement (84 words)

To determine gram-negative and gram-positive bacterial susceptibility against the antimicrobial agent Trovafloxacin.

Organisms with indications for testing* include:

Gram-Negative Bacteria Gram-Positive Bacteria

Escherichia coli Methicillin susceptible

Klebsiella pneumoniae Staphylococcus aureus

Proteus mirabilis Methicillin susceptible

Pseudomonas aeruginosa Staphylococcus epidermidis

Enterococcus faecalis

Streptococcus agalactiae (Gp.B)

Streptococcus pyogenes (Gp.A)

* As taken from the Indications and Usage section of the manufacturer’s package insert (Issued: December 1997).

The MicroScan® Dried Gram-Negative and Gram-Positive MIC/Combo Panels with Trovafloxacin are not intended for use with Streptococcus pneumoniae and viridans streptococci.

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/K983408 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983408: Dried Gram-Negative and Gram-Positive Mic/Combo Panels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983408

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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