# K943780: Negative Control Strips for Urinalysis (Chex-Stix, Clinitek Auto 2000, Clinitex Atlas)

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Oct 31, 1994 after 89 days
- Product code: JJW (Urinalysis Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 7 (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
- Nov 21, 2012 · Class III · Z-0637-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Nov 21, 2012 · Class III · Z-0639-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Nov 21, 2012 · Class II · Z-0640-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Nov 21, 2012 · Class III · Z-0641-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Nov 21, 2012 · Class III · Z-0635-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Nov 21, 2012 · Class III · Z-0636-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).
- Nov 21, 2012 · Class III · Z-0638-2013: When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).

Source page: https://510kreport.com/device/K943780
Methodology: https://510kreport.com/methodology