Romcheck Specimen Collection Kit

• • Ongoing Z-1095-2025 FDA Class II ·initiated 8 Jan 2025

  Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extraction buffer. The transport tubes are used with the Fetal Fibronectin Enzyme Immunoassay and Rapid fFN for the TLiIQ System which aids in assessing the risk of preterm delivery. The use of empty transport tubes or transport tubes containing insufficient extraction buffer volume may result in invalid results and/or delays in obtaining results. Additionally, the use of underfilled tubes may result in false positive results and the use of overfilled tubes may result in false negative results.

• • Terminated Z-1658-2011 FDA Unclassified (pre-2012) ·initiated 15 Dec 2009 ·on shared 510(k) K900225

  Product name change requires conversion to a different type of PMA and implies that the product could be used to assess whether a patient's pregnancy is full term, or to predict imminent delivery in women who are at full term gestation.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K900225 ↗

FDA Product Code

LIO

Device Class

Class I

Regulation

21 CFR Part 866.2900

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Oba(Tm) Serum Hcg Assay

  Class II

  FDA 510(k) K911047 Active Cleared 24 Jun 1991

• Oba(Tm) Reader

  Class I

  FDA 510(k) K911045 Active Cleared 24 Jun 1991