Cleared Traditional

K981101 - STRATUS CS MYO CALPAK

K981101 is an FDA 510(k) clearance for STRATUS CS MYO CALPAK, manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K981101 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
20d
Days
Class 2
Risk

K981101 is an FDA 510(k) clearance for the STRATUS CS MYO CALPAK. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 15, 1998 after a review of 20 days - a notably fast clearance cycle.

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: 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 Behring, Inc. devices

FDA 510(k) Submission Details - K981101

510(k) Number K981101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1998
Decision Date April 15, 1998
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 208
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K981101.
PREALBUMIN CALIBRATOR
K982292 · Dade Behring, Inc. · Aug 1998
STRATUS CS CKMB CALPAK
K981097 · Dade Behring, Inc. · Apr 1998
STRATUS CS TROP CALPAK
K981100 · Dade Behring, Inc. · Apr 1998
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668 · Dade Intl., Inc. · Oct 1997
PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR
K973100 · Dade Chemistry Systems, Inc. · Sep 1997
ELECSYS CEA ASSAY
K964368 · Boehringer Mannheim Corp. · Jun 1997