Trepchek Treponemal Antibody Eia

510(k) K001552

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK001552	Date19 Oct 2000Cleared	StatusActive

3 recalls · FDA

- Terminated Z-0784-05 FDA Unclassified (pre-2012) initiated 16 Mar 2005
Package insert incorrectly states that specimen diluent is ready to use, however specimen diluent bottle in kit states that the diluent must be diluted to one liter.
- Terminated Z-0513-04 FDA Unclassified (pre-2012) initiated 9 Dec 2003
The test kit may have the potential to give erroneous results in that it may give higher frequency of equivocal/low positive results.
- Terminated Z-0325-05 FDA Unclassified (pre-2012) initiated 11 Sep 2003
Several customers complained that either the negative control index value exceeded the upper control limit or there was very low activity of the cut off calibrator causing patient sample test runs to be called invalid.

1 jurisdiction

United States — FDA 510(k) Active

510(k)