Cleared Traditional

K170005 - FLEX Monoclonal Mouse Anti-Human Proges...

K170005 is an FDA 510(k) clearance for FLEX Monoclonal Mouse Anti-Human Proges..., manufactured by Dako Denmark A/S. The device is a Class 2 Pathology device with product code MXZ cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K170005 · Dako Denmark A/S · Pathology device
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Dec 2017
Decision
352d
Days
Class 2
Risk

K170005 is an FDA 510(k) clearance for the FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready.... Classified as Immunohistochemistry Assay, Antibody, Progesterone Receptor (product code MXZ), Class II - Special Controls.

Submitted by Dako Denmark A/S (Golstrup, DK). The FDA issued a Cleared decision on December 21, 2017 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1860 - the FDA pathology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dako Denmark A/S devices

FDA 510(k) Submission Details - K170005

510(k) Number K170005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2017
Decision Date December 21, 2017
Days to Decision 352 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 77d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MXZ Device Classification - Class 2, Special Controls

Product Code MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.1860
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 Pathology devices follow this clearance model.

Regulatory Peers - MXZ Immunohistochemistry Assay, Antibody, Progesterone Receptor

Devices cleared under the same product code (MXZ) and FDA review panel - the closest regulatory comparables to K170005.
BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format).
K193393 · Leica Biosystems Newcastle, Ltd. · Mar 2020
BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody
K183102 · Leica Biosystems Newcastle, Limited · Dec 2018
DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING
K020023 · Dako Corp. · Feb 2002
VENTANA PGR PRIMARY ANTIBODY (CLONE 1A6)
K990618 · Ventana Medical Systems, Inc. · Jul 1999