Cleared Traditional

K850213 - ISOCONTROL SERUM CK-MB

K850213 is an FDA 510(k) clearance for ISOCONTROL SERUM CK-MB, manufactured by Sclavo, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K850213 · Sclavo, Inc. · Chemistry device
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Mar 1985
Decision
49d
Days
Class 1
Risk

K850213 is an FDA 510(k) clearance for the ISOCONTROL SERUM CK-MB. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on March 5, 1985 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Sclavo, Inc. devices

FDA 510(k) Submission Details - K850213

510(k) Number K850213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1985
Decision Date March 05, 1985
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme 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 - JJT Enzyme Controls (assayed And Unassayed)

All 80
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K850213.
V-TREND OC CPK
K854973 · V-Tech, Inc. · Jan 1986
DELTA TROL I & II
K853373 · Electro-Nucleonics Laboratories, Inc. · Aug 1985
CK/LD ISOENZYMES CONTROLS(HUMAN)
K851520 · Seragen Diagnostics, Inc. · Jun 1985
ISOCONTROL SERUM LD-
K850211 · Sclavo, Inc. · Feb 1985
ID ZINE LD ISOENZYME CONTROL ABNORM
K843265 · Beckman Instruments, Inc. · Sep 1984
ID ZONE NORMAL LD ISOENZYME CONTROL
K843266 · Beckman Instruments, Inc. · Sep 1984