# K030443: Mammary Aspiration Specimen Cytology Test

- Pathway: 510(k) (Traditional)
- Applicant: Nastech Pharmaceutical Company, Inc.
- Decided: May 9, 2003 after 87 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (1 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.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mammary Aspiration Specimen Cytology Test (MASCT): named in the summary without a submission number
- (no number) Pro.Duct Catheter: named in the summary without a submission number

## Recalls of this device
- Sep 19, 2013 · Class I · Z-0042-2014: Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due to concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter re

## Indications for use
The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.

Source page: https://510kreport.com/device/K030443
Methodology: https://510kreport.com/methodology