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510(k) K232027

CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument by Sebia — Product Code GKA

K232027 is an FDA 510(k) premarket notification submitted by Sebia for the device "CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument". The FDA issued a decision of Substantially Equivalent on April 4, 2024. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Sebia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2024
Date Received
July 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

Other clearances by Sebia

  • K231601 — FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 (February 23, 2024)
  • K210623 — FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 (November 18, 2022)
  • K203184 — HYDRASHIFT 2/4 isatuximab (November 12, 2021)
  • K192095 — CAPI 3 Immunotyping, Capillarys 3 Tera (November 1, 2019)
  • K190851 — HYDRASHIFT 2/4 daratumumab (May 2, 2019)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171861 — CAPILLARYS Hb A1c (February 7, 2018)
  • K172195 — HYDRASHIFT 2/4 daratumumab, daratumumab Control (January 11, 2018)
  • K171537 — CAPI 3 Hb A1c (September 12, 2017)
  • K162281 — CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) (February 17, 2017)

Other clearances for product code GKA

  • K222635 — Premier Resolution System (August 4, 2023)
  • K192931 — V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control (April 19, 2022)
  • K180762 — CAPI 3 HEMOGLOBIN(E) (December 14, 2018)
  • K171664 — Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview So (September 13, 2017)
  • K112550 — CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM (May 25, 2012)
  • K112491 — SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2 (May 24, 2012)
  • K091283 — CAPILLARYS NEONAT HB (PN 2006) (February 22, 2010)
  • K082227 — MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 (March 26, 2009)
  • K080911 — VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTE (May 2, 2008)
  • K052291 — CAPILLARY'S HEMOGLOBIN(E) (PN 2007) (June 27, 2006)

FDA data resources