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510(k) K052882

FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE by Tianjin New Bay Bioresearch Co., Ltd. — Product Code DKZ

K052882 is an FDA 510(k) premarket notification submitted by Tianjin New Bay Bioresearch Co., Ltd. for the device "FORSURE RAPID ONE STEP MULTIPLE(X) ABUSE DRUG SCREEN TEST CUP DEVICE". The FDA issued a decision of Substantially Equivalent on February 15, 2006. The device falls under product code DKZ (Enzyme Immunoassay, Amphetamine), a Class II device regulated under 21 CFR 862.3100. Tianjin New Bay Bioresearch Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2006
Date Received
October 12, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Amphetamine
Device Class
Class II
Regulation Number
862.3100
Review Panel
TX
Submission Type

Other clearances by Tianjin New Bay Bioresearch Co., Ltd.

  • K130275 — QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST (September 26, 2013)
  • K122064 — FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE (May 7, 2013)
  • K112449 — QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST (September 24, 2012)
  • K071489 — HOMECHECK MULTIPLE DRUG CUP TEST (March 28, 2008)
  • K073431 — FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HO (January 14, 2008)
  • K061617 — FORSURE ONE STEP DIP & READ (X) DRUG SCREEN TEST (November 22, 2006)
  • K052520 — RAPID FORSURE ONE STEP MULTIPLE DRUG (UP TO 6) SCREEN TEST DEVICE FOR AMPHETAMIN (April 24, 2006)
  • K052208 — GLUCOSE PILOT (December 9, 2005)
  • K042988 — RAPID ONE STEP BUPRENORPHINE TEST CARD (May 12, 2005)
  • K042990 — FOR SURE ONE STEP BUPRENORPHINE TEST STRIP (May 10, 2005)

Other clearances for product code DKZ

  • K240670 — DRI Ecstasy Plus Assay (October 30, 2024)
  • K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest (December 13, 2023)
  • K231137 — Xenta Drug Screen Cup, Xenta Drug Screen Dipcard (May 19, 2023)
  • K200363 — Quidel Triage® TOX Drug Screen, 94600 (March 11, 2020)
  • K191099 — Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (October 3, 2019)
  • K182719 — Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (June 19, 2019)
  • K182738 — Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Mul (March 27, 2019)
  • K180879 — BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi- (December 14, 2018)
  • K181945 — QuickScreen Pro Multi Drug Screening Test, Model 9395Z (October 18, 2018)
  • K173303 — INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT (February 23, 2018)

FDA data resources