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510(k) K980249

ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA by Princeton BioMeditech Corp. — Product Code LFG

K980249 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA". The FDA issued a decision of Substantially Equivalent on March 13, 1998. The device falls under product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1998
Date Received
January 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

Other clearances by Princeton BioMeditech Corp.

  • K251538 — Status™ COVID-19/Flu A&B (November 14, 2025)
  • K182157 — BioSign Flu A+B (September 18, 2018)
  • K130650 — STATUS DS OXY (February 26, 2014)
  • K133474 — BIOSIGN FLU A + B, STATUS FLU A & B (December 10, 2013)
  • K132465 — BIOSIGN FLU A + B, STATUS FLU A & B (September 9, 2013)
  • K083746 — BIOSIGN FLU A+B (November 10, 2010)
  • K100817 — BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (July 1, 2010)
  • K100341 — SPERMCHECK FERTILITY (May 4, 2010)
  • K082661 — BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A (October 6, 2008)
  • K073039 — SPERMCHECK VASECTOMY (January 24, 2008)

Other clearances for product code LFG

  • K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptylin (August 18, 2015)
  • K142609 — CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (December 18, 2014)
  • K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (September 9, 2011)
  • K072062 — UCP MULTIPLE DRUG SCREEN TEST CUPS (September 20, 2007)
  • K061457 — UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (August 21, 2006)
  • K021526 — ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (July 17, 2002)
  • K011545 — VERDICT -II TCA, VERDICT-II MTD (June 8, 2001)
  • K870823 — EMIT NORTRIPTYLINE ASSAY (March 20, 1987)
  • K861155 — EMIT DESIPRAMINE ASSAY (May 2, 1986)
  • K853113 — TD TRICYCLIC ANTIDEPRESSANTS (August 12, 1985)

FDA data resources