Cleared Traditional

K905757 - AIA-PACK HGH

K905757 is the FDA 510(k) clearance for AIA-PACK HGH by Tosoh Medics, Inc.. It is a Class 1 Chemistry device (product code CFL) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K905757 · Tosoh Medics, Inc. · Chemistry device
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Jan 1991
Decision
29d
Days
Class 1
Risk

K905757 is an FDA 510(k) clearance for the AIA-PACK HGH. Classified as Radioimmunoassay, Human Growth Hormone (product code CFL), Class I - General Controls.

Submitted by Tosoh Medics, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on January 25, 1991 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1370 - 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 Tosoh Medics, Inc. devices

Submission Details

510(k) Number K905757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date January 25, 1991
Days to Decision 29 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
59d faster than avg
Panel avg: 88d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFL Radioimmunoassay, Human Growth Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1370
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CFL Radioimmunoassay, Human Growth Hormone

All 21
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K896808 · Nichols Institute Diagnostics · Jan 1990
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K875229 · Diagnostic Systems Laboratories, Inc. · Jul 1988