Cleared Traditional

K951708 - ELSA-HCT

K951708 is an FDA 510(k) clearance for ELSA-HCT, manufactured by Cis-Us, Inc.. The device is a Class 2 Chemistry device with product code JKR cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K951708 · Cis-Us, Inc. · Chemistry device
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Sep 1995
Decision
145d
Days
Class 2
Risk

K951708 is an FDA 510(k) clearance for the ELSA-HCT. Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Cis-Us, Inc. (Bedford, US). The FDA issued a Cleared decision on September 5, 1995 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1140 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Cis-Us, Inc. devices

FDA 510(k) Submission Details - K951708

510(k) Number K951708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1995
Decision Date September 05, 1995
Days to Decision 145 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 88d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKR Device Classification - Class 2, Special Controls

Product Code JKR Radioimmunoassay, Calcitonin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1140
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 - JKR Radioimmunoassay, Calcitonin

All 16
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K951708.
NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT
K964635 · Nichols Institute Diagnostics · May 1997
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
K961043 · Scantibodies Laboratory, Inc. · May 1996
CALCITONIN IMMUNOASSAY KIT
K945961 · Nichols Institute Diagnostics · Nov 1995
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
K914429 · Diagnostic Systems Laboratories, Inc. · Jan 1992
MODIFIED CALCITONIN RIA KIT DSL #1200
K874087 · Diagnostic Systems Laboratories, Inc. · Feb 1988
DOUBLE ANTIBODY CALCITONIN RIA KIT
K861274 · Diagnostic Products Corp. · Jun 1986