Cleared Traditional

K992680 - ELECSYS PARATHYROID HORMONE TEST SYSTEM

K992680 is the FDA 510(k) clearance for ELECSYS PARATHYROID HORMONE TEST SYSTEM by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K992680 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
49d
Days
Class 2
Risk

K992680 is an FDA 510(k) clearance for the ELECSYS PARATHYROID HORMONE TEST SYSTEM. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 28, 1999 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - 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 K992680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date September 28, 1999
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 - CEW Radioimmunoassay, Parathyroid Hormone

All 46
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K992680.
NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY
K013992 · Nichols Institute Diagnostics · Dec 2001
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6
K013566 · Diagnostic Products Corp. · Nov 2001
IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6
K011505 · Diagnostic Products Corp. · Jul 2001
IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
K992105 · Diagnostic Products Corp. · Jul 1999
ACTIVE INTACT PTH
K973514 · Diagnostic Systems Laboratories, Inc. · Oct 1997
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · Nichols Institute Diagnostics · Dec 1996