Cleared Traditional

K920556 - TANDEM-E HCG CALIBRATION VERIFICATION CONTROL SET

K920556 is an FDA 510(k) clearance for TANDEM-E HCG CALIBRATION VERIFICATION C..., manufactured by Hybritech, Inc.. The device is a Class 1 Chemistry device with 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

FDA 510(k) Submission Details - K920556

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.

JJX Device Classification - Class 1, General Controls

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 454
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K920556.
DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET
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LIPID CONTROLS
K922995 · Creative Laboratory Products, Inc. · Aug 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
HCG CONTROL
K921206 · Polymedco, Inc. · Apr 1992