Cleared Traditional

K982022 - VIGIL HEMOGLOBIN (HBALC) CONTROLS

K982022 is an FDA 510(k) clearance for VIGIL HEMOGLOBIN (HBALC) CONTROLS, manufactured by Beckman Coulter, Inc.. The device is a Class 1 Hematology device with product code JJX cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K982022 · Beckman Coulter, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
27d
Days
Class 1
Risk

K982022 is an FDA 510(k) clearance for the VIGIL HEMOGLOBIN (HBALC) CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on July 6, 1998 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1660 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K982022

510(k) Number K982022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1998
Decision Date July 06, 1998
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 444
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K982022.
ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05
K983578 · Bio-Rad · Nov 1998
B2-MICROGLOBULIN CONTROL SET SERUM
K982471 · Boehringer Mannheim Corp. · Aug 1998
DADE TRU-LIQUID CARDIAC CONTROL
K982591 · Dade Behring, Inc. · Aug 1998
ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
K981864 · Beckman Coulter, Inc. · Jun 1998
DADE TRU-LIQUID CARDIAC CONTROL
K981622 · Dade Behring, Inc. · Jun 1998
ELECSYS CALCHECK FERRITIN
K981281 · Roche Diagnostics GmbH · Apr 1998