Cleared Traditional

K922754 - TANDEM-E IGE II CALIBRATION VERIFICATIO...

K922754 is the FDA 510(k) clearance for TANDEM-E IGE II CALIBRATION VERIFICATIO... by Hybritech, Inc.. It is a Class 1 Immunology device (product code JJX) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K922754 · Hybritech, Inc. · Immunology device
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Feb 1993
Decision
254d
Days
Class 1
Risk

K922754 is an FDA 510(k) clearance for the TANDEM-E IGE II CALIBRATION VERIFICATION SET. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 17, 1993 after a review of 254 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hybritech, Inc. devices

Submission Details

510(k) Number K922754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date February 17, 1993
Days to Decision 254 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 104d · This submission: 254d
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)

All 371
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REFRACTROL-SP
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