Cleared Traditional

K994200 - ACCESS HYBRITECH PSA QC

K994200 is the FDA 510(k) clearance for ACCESS HYBRITECH PSA QC by Beckman Coulter, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K994200 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
36d
Days
Class 1
Risk

K994200 is an FDA 510(k) clearance for the ACCESS HYBRITECH PSA QC, MODEL 37209. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 18, 2000 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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

Submission Details

510(k) Number K994200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date January 18, 2000
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 104d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K994200.
TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
K000231 · Biosite Incorporated · Mar 2000
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) CONTROLS
K000230 · Biosite Incorporated · Feb 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K000318 · Bionostics, Inc. · Feb 2000
ACCESS OSTASE QC
K994277 · Beckman Coulter, Inc. · Jan 2000
ACCESS HYBRITECH FREE PSA QC, MODEL 37219
K993210 · Beckman Coulter, Inc. · Jan 2000
ELECSYS PARATHYROID HORMONE CALCHECK
K993642 · Roche Diagnostics Corp. · Nov 1999