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510(k) K191147

OC-Auto SENSOR io iFOB Test by Eiken Chemical Co., Ltd. — Product Code OOX

K191147 is an FDA 510(k) premarket notification submitted by Eiken Chemical Co., Ltd. for the device "OC-Auto SENSOR io iFOB Test". The FDA issued a decision of Substantially Equivalent on January 2, 2020. The device falls under product code OOX (Automated Occult Blood Analyzer), a Class II device regulated under 21 CFR 864.6550. Eiken Chemical Co., Ltd. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 2020
Date Received
April 30, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Automated Occult Blood Analyzer
Device Class
Class II
Regulation Number
864.6550
Review Panel
HE
Submission Type

The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.

Other clearances by Eiken Chemical Co., Ltd.

  • K143325 — OC-Light S FIT (August 20, 2015)
  • K864342 — MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX (December 1, 1986)
  • K853391 — MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000 (October 1, 1985)

Other clearances for product code OOX

  • K200754 — Hemosure Accu-Reader A100 (June 2, 2022)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K132167 — I-CHROMA IFOB WITH I-CHROMA READER (May 2, 2014)
  • K092330 — OC-SENSOR DIANA IFOB TEST (January 8, 2010)
  • K041408 — POLYMEDCO OC AUTO MICRO 80 FOB TEST (October 21, 2004)

FDA data resources