510(k) K221175

Multi-Lancet Device 2, ReliOn Premier Lancing Device by Arkray, Inc. — Product Code QRL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 17, 2022
Date Received: April 25, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multiple Use Blood Lancet For Single Patient Use Only
Device Class: Class II
Regulation Number: 878.4850
Review Panel: SU
Submission Type

A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances by Arkray, Inc.

K232416 — AUTION EYE AI-4510 Urine Particle Analysis System (May 3, 2024)
K193514 — AUTION MAX AX-4060 Urinalysis System (April 13, 2023)
K200788 — Assure Titanium Blood Glucose Monitoring System (May 23, 2022)
K160062 — AUTION ELEVEN Semi-Automated Urinalysis System (October 7, 2016)
K121456 — AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET (February 1, 2013)
K093098 — AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM (December 23, 2009)
K053401 — SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS (March 24, 2006)
K051648 — SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS (January 31, 2006)
K051432 — SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS (June 17, 2005)
K050790 — SPOTCHEM II LDH TEST (June 6, 2005)

Other clearances for product code QRL

K253706 — Lancing device (HH-XV-T) (December 9, 2025)
K250813 — MICROLET®NEXT 2 Lancing Device (May 14, 2025)
K243306 — Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); La (November 15, 2024)
K232912 — Facet Aurora Reusable Lancet Base (January 25, 2024)
K231797 — Medifun Lancing Device, Model No. LD-E1 (November 22, 2023)
K223643 — Verifine® Ease Lancing Device, Verifine® Lancing Device (February 21, 2023)
K221419 — TD-5010 Lancing Device and TD-5084 Sterile Lancets (January 20, 2023)
K222472 — Lancing System, Sterile Lancet for Single Use, Lancing Device (November 30, 2022)
K223099 — Facet Manatee Reusable Lancing Base (November 28, 2022)
K222656 — LDE4 Lancing Device (November 23, 2022)