# K970824: MDX 2000, Digital Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shotwell & Carr, Inc.
- Decided: May 30, 1997 after 85 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Nikon Biostation: named in the summary without a submission number
- (no number) Intelligent Imaging, Inc. Model IMS-200 automated cell locating device: named in the summary without a submission number
- (no number) Sigma Diagnostics’ alkaline phosphatase reagent system FAST VIOLET B SALT, catalog No. 85-1: named in the summary without a submission number

## Indications for use
Automated scanning microscopy work station for histological identification of the enzyme leucocyte alkaline phosphatase in neutrophilic granulocytes to differentiate: * Granulocytic leukemia, a malignant disease characterized by excessive overgrowth of granulocytes in bone marrow, and * Reactions that resemble true leukemia, such as those occurring in severe infections.

Source page: https://510kreport.com/device/K970824
Methodology: https://510kreport.com/methodology