Home / 510(k) Clearances / K170652

510(k) K170652

ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls by Fisher Diagnostics — Product Code PRI

K170652 is an FDA 510(k) premarket notification submitted by Fisher Diagnostics for the device "ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls". The FDA issued a decision of Substantially Equivalent on June 1, 2017. The device falls under product code PRI (Procalcitonin Assay), a Class II device regulated under 21 CFR 866.3215. Fisher Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2017
Date Received
March 3, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Procalcitonin Assay
Device Class
Class II
Regulation Number
866.3215
Review Panel
MI
Submission Type

To aid in decision making on antibiotic therapy, including antibiotic initiation and discontinuation, for inpatients or patients in the Emergency Department, with suspected or confirmed lower respiratory tract infections (LRTI) defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).

Other clearances by Fisher Diagnostics

  • K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN (September 13, 2007)
  • K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS (July 18, 2006)
  • K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY C (May 10, 2006)
  • K042924 — ARCHITECT STAT MYO IMMUNOASSAY (January 24, 2005)
  • K041192 — ARCHITECT STAT TROPONIN-I IMMUNOASSAY (August 12, 2004)
  • K041596 — ARCHITECT STAT CK-MB IMMUNOASSAY (July 21, 2004)
  • K023362 — FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLU (December 9, 2002)
  • K013397 — PACIFIC HEMOSTASIS REFERENCE EMULSION (February 15, 2002)
  • K010750 — PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560 (September 7, 2001)
  • K850160 — FISHER DIAGNOSTICS LATEST-CRP TEST KIT (April 19, 1985)

Other clearances for product code PRI

  • K220262 — Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (August 26, 2022)
  • K192815 — Elecsys BRAHMS PCT (March 9, 2020)
  • K173927 — Elecsys BRAHMS PCT (July 6, 2018)
  • K173683 — LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT (February 27, 2018)
  • K172713 — Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S P (December 10, 2017)
  • K171338 — B R A H M S PCT sensitive KRYPTOR (May 31, 2017)
  • K162827 — VIDAS B.R.A.H.M.S. PCT (PCT) (February 23, 2017)

FDA data resources