Cleared Traditional

K983850 - DIMENSION AHDL CALIBRATOR

K983850 is the FDA 510(k) clearance for DIMENSION AHDL CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K983850 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
19d
Days
Class 2
Risk

K983850 is an FDA 510(k) clearance for the DIMENSION AHDL CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 19 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K983850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date November 18, 1998
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
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 145
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K983850.
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824 · Dade Behring, Inc. · Apr 1999
DIMENSION SPECIAL PROTEIN CALIBRATOR
K990554 · Dade Behring, Inc. · Mar 1999
DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR
K984193 · Dade Behring, Inc. · Dec 1998
DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
K983693 · Dade Behring, Inc. · Nov 1998
STRATUS CS TROPONIN I CALIBRATOR
K983722 · Dade Behring, Inc. · Nov 1998
FERRITIN CALIBRATOR
K983548 · Dade Behring, Inc. · Oct 1998