Cleared Traditional

K902575 - SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)

K902575 is an FDA 510(k) clearance for SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL), manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code JIW cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K902575 · Diagnostic Products Corp. · Chemistry device
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Oct 1990
Decision
115d
Days
Class 2
Risk

K902575 is an FDA 510(k) clearance for the SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL). Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 4, 1990 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K902575

510(k) Number K902575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1990
Decision Date October 04, 1990
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIW Device Classification - Class 2, Special Controls

Product Code JIW Calibrator, Surrogate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIW Calibrator, Surrogate

All 14
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K902575.
WAKO CH50 LINEARITY SET
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HUMAN CHORIONIC GONADOTROPIN CALIBRATOR
K970396 · Dade Chemistry Systems, Inc. · Feb 1997
FLOW CYTOMETRY FITC/PE COMPENSATION KIT
K910255 · Sigma Diagnostics, Inc. · Apr 1991
ACCUSCAN MICROBEAD STANDARDS
K902294 · Sigma Chemical Co. · Jul 1990
ACS COLLOID OSMOTIC PRESSURE CALIBRATOR
K892213 · Analytical Control Systems, Inc. · Jun 1989
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD
K883389 · Reagents Applications, Inc. · Dec 1988