Cleared Traditional

K982831 - AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U

K982831 is an FDA 510(k) clearance for AUTO-LYTE BENZODIAZEPINES EIA MODEL NUM..., manufactured by OraSure Technologies, Inc.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K982831 · OraSure Technologies, Inc. · Toxicology device
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Nov 1998
Decision
93d
Days
Class 2
Risk

K982831 is an FDA 510(k) clearance for the AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by OraSure Technologies, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 12, 1998 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all OraSure Technologies, Inc. devices

FDA 510(k) Submission Details - K982831

510(k) Number K982831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1998
Decision Date November 12, 1998
Days to Decision 93 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 87d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - JXM Enzyme Immunoassay, Benzodiazepine

All 84
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K982831.
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
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MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
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ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
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QUICKSCREEN BENZODIAZEPINES SCREENING TEST MODEL NUMBERS 9025,9026 AND QUICKSCREEN PRO MULTI DRUG SCREENING TEST MODEL 1
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K980776 · Tcpi, Inc. · Apr 1998
QUIKSTRIP ONE STEP BENZODIAZEPINE TEST
K973269 · Drial Consultants, Inc. · Feb 1998