Cleared Traditional

B-HCG HUMAN SERUM CONTROLS (K932479) - FDA 510(k) Clearance

Class I Chemistry device.

K932479 · Pyramid Biological Corp. · Chemistry device
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Dec 1993
Decision
192d
Days
Class 1
Risk

K932479 is an FDA 510(k) clearance for the B-HCG HUMAN SERUM CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on December 2, 1993 after a review of 192 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Pyramid Biological Corp. devices

Submission Details

510(k) Number K932479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1993
Decision Date December 02, 1993
Days to Decision 192 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 88d · This submission: 192d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

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