Cleared Traditional

K003098 - ACCESS ULTRASENSITIVE HGH CALIBRATORS

K003098 is the FDA 510(k) clearance for ACCESS ULTRASENSITIVE HGH CALIBRATORS by Beckman Coulter, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K003098 · Beckman Coulter, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Nov 2000
Decision
48d
Days
Class 2
Risk

K003098 is an FDA 510(k) clearance for the ACCESS ULTRASENSITIVE HGH CALIBRATORS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (San Diego, US). The FDA issued a Cleared decision on November 20, 2000 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry 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 K003098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2000
Decision Date November 20, 2000
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 159
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K003098.
ELECSYS TESTOSTERONE CALSET II
K003411 · Roche Diagnostics Corp. · Mar 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · Dade Behring, Inc. · Feb 2001
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp. · Jan 2001
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc. · Mar 2000
ELECSYS ESTRADIOL CALSET II
K992981 · Roche Diagnostics Corp. · Sep 1999
N PROTEIN STANDARD UY
K991705 · Dade Behring, Inc. · Jul 1999