Cleared Traditional

K861797 - ALLEGRO INTACT PARATHYROID HORMONE IMMU...

K861797 is the FDA 510(k) clearance for ALLEGRO INTACT PARATHYROID HORMONE IMMU... by Nichols Institute Diagnostics. It is a Class 2 Chemistry device (product code CEW) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K861797 · Nichols Institute Diagnostics · Chemistry device
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Jul 1986
Decision
74d
Days
Class 2
Risk

K861797 is an FDA 510(k) clearance for the ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY. Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Nichols Institute Diagnostics (Los Angeles, US). The FDA issued a Cleared decision on July 22, 1986 after a review of 74 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 Nichols Institute Diagnostics devices

Submission Details

510(k) Number K861797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1986
Decision Date July 22, 1986
Days to Decision 74 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 88d · This submission: 74d
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 50
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K861797.
CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY
K882560 · Ciba Corning Diagnostics Corp. · Oct 1988
N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
K874299 · Incstar Corp. · Nov 1987
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2
K871970 · Diagnostic Products Corp. · Sep 1987
C-TERMINAL PTH RIA KIT
K853784 · Diagnostic Systems Laboratories, Inc. · Oct 1985
PARATHYROID HORMONE MID-MOLECULE RIA-KIT
K843870 · Diagnostic Products Corp. · Oct 1984
PARATHYROID HORMONE C-TERMINAL RIA KIT
K843871 · Diagnostic Products Corp. · Oct 1984