Cleared Traditional

K970176 - HCG CONTROLS

K970176 is an FDA 510(k) clearance for HCG CONTROLS, manufactured by International Newtech Development, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K970176 · International Newtech Development, Inc. · Chemistry device
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Feb 1997
Decision
20d
Days
Class 1
Risk

K970176 is an FDA 510(k) clearance for the HCG CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by International Newtech Development, Inc. (Richmond, B.C., CA). The FDA issued a Cleared decision on February 6, 1997 after a review of 20 days - a notably fast clearance 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: 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 International Newtech Development, Inc. devices

FDA 510(k) Submission Details - K970176

510(k) Number K970176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1997
Decision Date February 06, 1997
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
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 421
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K970176.
ELECSYS CALCHECK CEA
K970459 · Boehringer Mannheim Corp. · Mar 1997
ABBOTT HCG SERUM CONTROLS
K970527 · Abbott Laboratories · Mar 1997
ELECSYS CALCHECK ESTRADIOL
K970148 · Boehringer Mannheim Corp. · Feb 1997
ELECSYS CALCHECK TESTOSTERONE
K970146 · Boehringer Mannheim Corp. · Jan 1997
ELECSYS CALCHECK LH
K964830 · Boehringer Mannheim Corp. · Dec 1996
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6
K964278 · Clinical Controls, Inc. · Nov 1996