Cleared Traditional

K992981 - ELECSYS ESTRADIOL CALSET II

K992981 is the FDA 510(k) clearance for ELECSYS ESTRADIOL CALSET II by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K992981 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
21d
Days
Class 2
Risk

K992981 is an FDA 510(k) clearance for the ELECSYS ESTRADIOL CALSET II. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 21 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K992981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date September 24, 1999
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 137
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K992981.
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp. · Jan 2001
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · Beckman Coulter, Inc. · Nov 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc. · Mar 2000
N PROTEIN STANDARD UY
K991705 · Dade Behring, Inc. · Jul 1999
OPUS TROPONIN I CALIBRATOR
K991176 · Dade Behring, Inc. · Jul 1999
REVISED C-REACTIVE PROTEIN CALIBRATOR
K990824 · Dade Behring, Inc. · Apr 1999