Cleared Traditional

K851043 - SUGAR-CHEX II

K851043 is the FDA 510(k) clearance for SUGAR-CHEX II by Streck Laboratories, Inc.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K851043 · Streck Laboratories, Inc. · Chemistry device
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Apr 1985
Decision
46d
Days
Class 1
Risk

K851043 is an FDA 510(k) clearance for the SUGAR-CHEX II. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Streck Laboratories, Inc. (Omaha, US). The FDA issued a Cleared decision on April 29, 1985 after a review of 46 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 Streck Laboratories, Inc. devices

Submission Details

510(k) Number K851043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1985
Decision Date April 29, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K851043.
ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040
K860453 · Sigma Diagnostics, Inc. · Feb 1986
ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL
K855225 · Boehringer Mannheim Corp. · Jan 1986
SUGAR-CHEX
K851042 · Streck Laboratories, Inc. · Apr 1985
BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3
K851079 · Beckman Instruments, Inc. · Apr 1985
PRECISET AMMONIA
K843569 · Boehringer Mannheim Corp. · Sep 1984
CHEM TRAK LIQUID BILIRUBIN CONTROL
K833097 · Medical Analysis Systems, Inc. · Jan 1984