# K993679: Microstrep Plus Panel - Haemophilus/Ampicillin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Microscan, Inc.
- Decided: Jan 14, 2000 after 74 days
- Product code: JWY (Manual Antimicrobial Susceptibility Test Systems)
- Device class: 2
- Regulation: 21 CFR 866.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963641 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963641: Streptococcus Mic Panel, Dade Microscan, Inc. (1996) Summary page 1.

## Indications for use
The intended use of this panel is for determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of Haemophilus spp. After incubation in a non-CO, incubator for 20 — 24 hours, the minimum inhibitory concentration (MIC) for the test organism is determined by observing the lowest antimicrobial concentration showing inhibition of growth. The two-fold dilutions of AMPICILLIN in the panel range from 0.015 to 16 mcg/ml for testing Haemophilus spp.

Source page: https://510kreport.com/device/K993679
Methodology: https://510kreport.com/methodology