510(k) · Cleared

Cleared

Microscan Microstrep Plus Panel - Chloramphenicol

K021018510(k) TraditionalCleared Jun 11, 200274-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 Jun 11, 2002 as substantially equivalent to K963641 (Dade Microscan, Inc., 1996) after a 74-day review. Its family tree reaches back 1 generation to 1996.

Decided: Jun 11, 2002
Review: 74 days
Class: Class II
Product code: JWY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K963641 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK963641 Streptococcus Mic PanelDade Microscan, Inc. · 1996
This deviceK021018 Microscan Microstrep Plus Panel - ChloramphenicolDade Microscan, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K963641	Streptococcus Mic Panel	Dade Microscan, Inc.	1996	—
0 (this device)	K021018	Microscan Microstrep Plus Panel - Chloramphenicol	Dade Microscan, Inc.	2002	—

FIG. 1 — Lineage of K021018, 1996–2002Source: 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
*	K963641	Streptococcus Mic Panel Summary page 1 …ilitywith aerobic streptococci, including Streptococcus pneumoniae Predicate device: Microscan@Streptococcus MIC Panel 6963641). 51O(k) Summary: The MicroScan@MICroSTREP pZusTMPanel is used to determine quantitative andlor qualitative antimicr…	Dade Microscan, Inc.	1996	—

Also cleared against K963641: 21 other devices →

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?

Its one ancestor has no recall.
21 other devices also cite its predicate K963641.

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?

The Microscan® MICroSTREP plus™ Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert.

This particular submission is for the addition of the antimicrobial Chloramphenicol at concentrations of 1 to 32 mcg/ml to the test panel

The organisms which may be used for Chloramphenicol susceptibility testing in this panel are:

Susceptible streptococci, including Streptococcus pneumoniae

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021018 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021018: Microscan Microstrep Plus Panel - Chloramphenicol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021018

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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