# K971405: Speciality Urine 1,2

- Pathway: 510(k) (Traditional)
- Applicant: Chiron Diagnostics Corp.
- Decided: Jun 16, 1997 after 61 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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) Pharmacia: named in the summary without a submission number
- (no number) Bard Diagnostic Sciences: named in the summary without a submission number
- (no number) Diagnostic Systems Laboratories, Inc.: named in the summary without a submission number
- (no number) Ciba Corning Urine 1,2: named in the summary without a submission number
- (no number) Chiron ACS 180: named in the summary without a submission number
- (no number) Metra Biosystems, Inc.: named in the summary without a submission number
- (no number) Ostex: named in the summary without a submission number

## Indications for use
Speciality Urine 1,2 is used to monitor miscellaneous specialized urine constituents and bone resorption test procedures.

Source page: https://510kreport.com/device/K971405
Methodology: https://510kreport.com/methodology