Cleared Traditional

K131536 - IMMULITE 2000 PSA CALIBRATION VERIFICAT...

K131536 is an FDA 510(k) clearance for IMMULITE 2000 PSA CALIBRATION VERIFICAT..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 1 Immunology device with product code JJX cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K131536 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Aug 2013
Decision
75d
Days
Class 1
Risk

K131536 is an FDA 510(k) clearance for the IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 12, 2013 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1660 - the FDA immunology 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: 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 Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K131536

510(k) Number K131536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2013
Decision Date August 12, 2013
Days to Decision 75 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 104d · This submission: 75d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 402
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