Cleared Traditional

K973100 - PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

K973100 is an FDA 510(k) clearance for PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR, manufactured by Dade Chemistry Systems, Inc.. The device is a Class 2 Immunology device with product code JIT cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K973100 · Dade Chemistry Systems, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
41d
Days
Class 2
Risk

K973100 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on September 29, 1997 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - 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 Dade Chemistry Systems, Inc. devices

FDA 510(k) Submission Details - K973100

510(k) Number K973100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1997
Decision Date September 29, 1997
Days to Decision 41 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
64d faster than avg
Panel avg: 105d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
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 Immunology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 206
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K973100.
STRATUS CS TROP CALPAK
K981100 · Dade Behring, Inc. · Apr 1998
STRATUS CS MYO CALPAK
K981101 · Dade Behring, Inc. · Apr 1998
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668 · Dade Intl., Inc. · Oct 1997
ELECSYS CEA ASSAY
K964368 · Boehringer Mannheim Corp. · Jun 1997
MMB CALIBRATOR
K970336 · Dade Chemistry Systems, Inc. · Mar 1997
THYROID CALIBRATOR
K970389 · Dade Chemistry Systems, Inc. · Feb 1997