Cleared Traditional

K920556 - TANDEM-E HCG CALIBRATION VERIFICATION C...

K920556 is the FDA 510(k) clearance for TANDEM-E HCG CALIBRATION VERIFICATION C... by Hybritech, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K920556 · Hybritech, Inc. · Chemistry device
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Jul 1992
Decision
162d
Days
Class 1
Risk

K920556 is an FDA 510(k) clearance for the TANDEM-E HCG CALIBRATION VERIFICATION CONTROL 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 July 17, 1992 after a review of 162 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 Hybritech, Inc. devices

Submission Details

510(k) Number K920556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1992
Decision Date July 17, 1992
Days to Decision 162 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 88d · This submission: 162d
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
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K920556.
DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET
K923794 · Casco Standards · Nov 1992
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
K923821 · Casco Standards · Nov 1992
RAI-TROL FRUCTOSAMINE SERUM CONTROLS I AND II
K922904 · Reagents Applications, Inc. · Jul 1992
TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
K921252 · Hybritech, Inc. · Jul 1992
LYPHOCHEK(R) FRUCTOSAMINE CONTROL
K921089 · Bio-Rad · Apr 1992
MILENIA DATA REDUCTION
K915806 · Diagnostic Products Corp. · Jan 1992