# K931374: Affirm Vpiii Microbial Identification Test

- Pathway: 510(k) (Traditional)
- Applicant: Microprobe Corp.
- Decided: Jun 15, 1993 after 89 days
- Product code: MLA (Dna Probe, Yeast)
- Device class: 1
- Regulation: 21 CFR 866.2660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Aug 27, 2015 · Class II · Z-1394-2017: BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would 

Source page: https://510kreport.com/device/K931374
Methodology: https://510kreport.com/methodology