Cleared Traditional

K102779 - EMIT II PLUS6-ACETYLMORPHINE ASSAY

Also marketed or referenced as:
EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1 EMIT II PLUS 6-AM / ECTASY C

K102779 is an FDA 510(k) clearance for EMIT II PLUS6-ACETYLMORPHINE ASSAY, manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K102779 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
175d
Days
Class 2
Risk

K102779 is an FDA 510(k) clearance for the EMIT II PLUS6-ACETYLMORPHINE ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on March 18, 2011 after a review of 175 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K102779

510(k) Number K102779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date March 18, 2011
Days to Decision 175 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
87d slower than avg
Panel avg: 88d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 190
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