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510(k) K010550

VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 by bioMerieux, Inc. — Product Code LTJ

K010550 is an FDA 510(k) premarket notification submitted by bioMerieux, Inc. for the device "VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428". The FDA issued a decision of Substantially Equivalent on April 24, 2001. The device falls under product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers), a Class II device regulated under 21 CFR 866.6010. bioMerieux, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2001
Date Received
February 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Device Class
Class II
Regulation Number
866.6010
Review Panel
IM
Submission Type

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Other clearances for product code LTJ

  • K251630 — Atellica IM Total PSA II (tPSAII) (January 5, 2026)
  • K162378 — FREND PSA PLUS (reagent cartridge) (May 17, 2017)
  • K124056 — FREND PSA PLUS (REAGENT CARTRIDGE) (May 29, 2013)
  • K031343 — TPSA FLEX REAGENT CARTRIDGE (May 15, 2003)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
  • K003963 — DIMENSION PSA FLEX REAGENT CARTRIDGE (February 28, 2001)
  • K002376 — ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (October 26, 2000)
  • K003094 — FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (October 25, 2000)
  • K002313 — COMPLEXED PSA MICROTITER ELISA (August 30, 2000)

FDA data resources