# K970862: Spinalscopics

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Apr 8, 1997 after 32 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) QuanTscopics Urine Microscopics Control: named in the summary without a submission number

## Most influential descendants
- K020229: R & D Body Fluid Control (2002), 1 descendant of its own
- K041240: Semen Analysis Quality Control, Assayed and Unassayed (2004), 0 descendants of its own

## Recalls of this device
- Jun 1, 2007 · Not classified · Z-0515-2009: This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group.

## Indications for use
The Quantimetrix Spinalscopics Control is intended for monitoring cell counts performed manually using a hemocytometer to validate quantitation of red and white blood cells in patient CSF samples. The Spinalscopics Control is intended for use as Quality Control materials having known component concentrations. Daily monitoring of the control values establishes intralaboratory parameters for accuracy and precision of the manual cell counting methods.

Source page: https://510kreport.com/device/K970862
Methodology: https://510kreport.com/methodology