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510(k) K161158

IDS-iSYS Intact PTHN by Immunodiagnostic Systems , Ltd. — Product Code CEW

K161158 is an FDA 510(k) premarket notification submitted by Immunodiagnostic Systems , Ltd. for the device "IDS-iSYS Intact PTHN". The FDA issued a decision of Substantially Equivalent on January 31, 2017. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Immunodiagnostic Systems , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2017
Date Received
April 25, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Immunodiagnostic Systems , Ltd.

  • K202136 — IDS Cortisol (April 13, 2021)
  • K200475 — IDS-iSYS Ostase BAP (September 30, 2020)
  • K190121 — IDS SHBG (June 17, 2019)
  • K161831 — IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (November 15, 2016)
  • K161082 — IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration (May 17, 2016)
  • K142351 — 25-Hydroxy Vitamin Ds EIA (August 25, 2015)
  • K142994 — IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone (April 21, 2015)
  • K143324 — IDS-iSYS CTX-I Calibration Verifiers (March 30, 2015)
  • K140554 — IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET (December 19, 2014)
  • K123763 — IDS ISYS DIRECT RENIN ASSAY, IDS ISYS DIRECT RENIN CONTROL SET, AND IDS ISYS DIR (December 24, 2013)

Other clearances for product code CEW

  • K231927 — Elecsys PTH , Elecsys PTH STAT (March 22, 2024)
  • K232791 — Access Intact PTH (March 1, 2024)
  • K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (September 5, 2023)
  • K190702 — Lumipulse G whole PTH (August 30, 2019)
  • K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (May 23, 2017)
  • K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration (June 22, 2015)
  • K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (February 5, 2014)
  • K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (November 8, 2013)
  • K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (March 21, 2013)
  • K103325 — IDS-ISYS INTACT PTH (February 3, 2012)

FDA data resources