Cleared Traditional

K812222 - EM-X

K812222 is an FDA 510(k) clearance for EM-X, manufactured by Biological Corp. of America. The device is a Class 2 Immunology device with product code KSG cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K812222 · Biological Corp. of America · Immunology device
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Sep 1981
Decision
47d
Days
Class 2
Risk

K812222 is an FDA 510(k) clearance for the EM-X. Classified as Media, Potentiating For In Vitro Diagnostic Use (product code KSG), Class II - Special Controls.

Submitted by Biological Corp. of America (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.9600 - 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.

FDA 510(k) Submission Details - K812222

510(k) Number K812222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1981
Decision Date September 23, 1981
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 105d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSG Device Classification - Class 2, Special Controls

Product Code KSG Media, Potentiating For In Vitro Diagnostic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9600
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 - KSG Media, Potentiating For In Vitro Diagnostic Use

All 10
Devices cleared under the same product code (KSG) and FDA review panel - the closest regulatory comparables to K812222.
ELUTION SOLUTION
K812565 · Biological Corp. of America · Oct 1981
PENTEX BOVINE ALBUMIN 30% SOLUTION
K800943 · Miles Laboratories, Inc. · May 1980
ORTHO ANTIBODY ENHANCEMENT SOLUTION
K791791 · Ortho Diagnostics, Inc. · Oct 1979
LOW IONIC STRENGTH SOLUTION (LISS)
K791113 · Hyland Therapeutic Div., Travenol Laboratories · Jun 1979
LO-ION
K790973 · Gamma Biologicals, Inc. · Jun 1979
DADE LOW IONIC STRENGTH SOLUITION (LISS)
K790776 · Dade, Baxter Travenol Diagnostics, Inc. · May 1979
K812222 · EM-X
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