Cleared Traditional

K833710 - BTC URINE LH ASSAY

K833710 is an FDA 510(k) clearance for BTC URINE LH ASSAY, manufactured by Btc Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CED cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K833710 · Btc Diagnostics, Inc. · Chemistry device
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Jan 1984
Decision
102d
Days
Class 1
Risk

K833710 is an FDA 510(k) clearance for the BTC URINE LH ASSAY. Classified as 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase (product code CED), Class I - General Controls.

Submitted by Btc Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1520 - 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 Btc Diagnostics, Inc. devices

FDA 510(k) Submission Details - K833710

510(k) Number K833710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1983
Decision Date January 30, 1984
Days to Decision 102 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 88d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

CED Device Classification - Class 1, General Controls

Product Code CED 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1520
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 - CED 5-amp-phosphate Release (colorimetric Test), 5'-nucleotidase

All 7
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