510(k) Report

PMA · Approved

Recalled · Class I · 2014

Microscan Rapid Panels

P870049PMAApproved Feb 24, 1988188-day reviewClass II21 CFR 866.1645Recalls 3 (2 Class I)

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

Dade Intl., Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Approved on Feb 24, 1988 through premarket approval, which rests on the device’s own clinical evidence after a 188-day review. It has a Class I recall. It has been recalled 3 times, including 2 Class I recalls.

Decided
Feb 24, 1988
Review
188 days
Class
Class II
Product code
LON
Recalls
3 (2 Class I)

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P870049 has 27 supplements since 1989: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

1989: 31990: 31991: 61992: 11993: 11994: 41995: 11996: 21998: 11999: 22000: 12001: 2
1989high 6 (1991) · low 0 (1997)2001
View FIG. 1 as a table
YearSupplements approved
19893
19903
19916
19921
19931
19944
19951
19962
19981
19992
20001
20012
FIG. 1 — Supplements to P870049, 1989–2001Source: FDA PMA database

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 LON device

  1. #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 17, 2014Class IZ-0171-2015Nonconforming Material/ComponentAn increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
Oct 17, 2014Class IZ-0170-2015Nonconforming Material/ComponentAn increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
Feb 7, 2005Not classifiedZ-0668-05OtherThere is a potential for reporting of false susceptible anti-microbic results that could result in inappropriate and/or less effective therapy.

No ancestor or descendant has a Class I recall.

How does its category compare?

All LON devices

LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LON

5in 2025

2007: 192008: 72009: 82010: 12011: 82012: 102013: 72014: 42016: 32017: 102018: 42019: 82020: 52021: 52022: 82023: 112024: 22025: 52026 (partial year): 4
2007high 19 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LON

90in 2025

2007: 50 days median2008: 66 days median2009: 76 days median2011: 85 days median2012: 200 days median2013: 115 days median2014: 90 days median2016: 242 days median2017: 89 days median2018: 88 days median2019: 84 days median2020: 81 days median2021: 268 days median2022: 189 days median2023: 210 days median2025: 90 days median2026 (partial year): 146 days median
2007high 268 (2021) · low 50 (2007)2026

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

Recalls per year · LON

1in 2025

2008: 12010: 1162011: 32012: 32014: 2, 2 Class I2016: 22017: 12018: 62019: 12020: 82022: 152024: 12025: 12026 (partial year): 6
2007high 116 (2010) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LON

690in 2025

2007: 32008: 12010: 32011: 42012: 92013: 32014: 102015: 412016: 942017: 1972018: 5122019: 3152020: 2182021: 2322022: 1802023: 4532024: 4182025: 690
2007high 690 (2025) · low 0 (2009)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007195003
200876611
200987600
20101—1163
201188534
20121020039
2013711503
20144902 (2)10
20150—041
20163242294
201710891197
20184886512
20198841315
20205818218
202152680232
2022818915180
2023112100453
20242—1418
20255901690
202641466—

More from Dade Intl., Inc.

58 FDA decisions under this applicant name. See the company

  • P870049/S032Microscan Rapid Gram Positive Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S031Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 2001
  • P870049/S030Microscan (R) Rapid Fluorogenic PanelsDade Intl., Inc. · 2000
  • P870049/S029Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999
  • P870049/S028Microscan Rapid Fluorogenic PanelsDade Intl., Inc. · 1999

Recent decisions in LON

The LON category page

  • K260283VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)bioMerieux, Inc. · 2026
  • K260619VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)Biomérieux, Inc. · 2026
  • K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc. · 2026
  • K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)Biomerieux · 2026
  • K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc. · 2025

https://510kreport.com/device/P870049 · printed Nov 6, 2026

Cite this page

510(k) Report. “P870049: Microscan Rapid Panels.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P870049

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026