Cleared Traditional

K780982 - KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT

K780982 is an FDA 510(k) clearance for KITS, manufactured by Cis Radiopharmaceuticals, Inc.. The device is a Class 2 Immunology device with product code DDR cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K780982 · Cis Radiopharmaceuticals, Inc. · Immunology device
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Jun 1978
Decision
8d
Days
Class 2
Risk

K780982 is an FDA 510(k) clearance for the KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), Class II - Special Controls.

Submitted by Cis Radiopharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5680 - the FDA immunology device 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 Cis Radiopharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K780982

510(k) Number K780982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1978
Decision Date June 22, 1978
Days to Decision 8 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 105d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDR Device Classification - Class 2, Special Controls

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 Immunology devices follow this clearance model.

Regulatory Peers - DDR Myoglobin, Antigen, Antiserum, Control

All 40
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K780982.
TURBIQUANT MYOGLOBIN
K903687 · Behring Diagnostics, Inc. · Oct 1990
NA LATEX MYOGLOBIN TEST
K902154 · Behring Diagnostics, Inc. · Jun 1990
MYOLEX
K863730 · Orion Corp. · Oct 1986
HEMAGGLUTINATION INHIBITION TEST
K772095 · Miles Laboratories, Inc. · Jan 1978
ANTISERA TO HUMAN FAB FRAGMENT
K771242 · Kent Laboratories, Inc. · Aug 1977