Cleared Traditional

K823353 - CARCINO-CEK

K823353 is an FDA 510(k) clearance for CARCINO-CEK, manufactured by Biologics Intl., Inc.. The device is a Class 1 Immunology device with product code JJX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823353 · Biologics Intl., Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
35d
Days
Class 1
Risk

K823353 is an FDA 510(k) clearance for the CARCINO-CEK. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Biologics Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 14, 1982 after a review of 35 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 Biologics Intl., Inc. devices

FDA 510(k) Submission Details - K823353

510(k) Number K823353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date December 14, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 105d · This submission: 35d
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 466
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K823353.
DAC-CEL DIAGNATAL HCG STANDARDS RD49
K830204 · Wellcome Diagnostics · Feb 1983
BIO INTERFERENCE BLANKING MATERIAL
K823687 · American Monitor Corp. · Jan 1983
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K822219 · Hoffmann-La Roche, Inc. · Dec 1982
PHADEBASE HUMYLASE CONTROL
K822938 · Pharmacia, Inc. · Nov 1982
GLUCOSCAN CONTROLS
K822698 · Lifescan, Inc. · Sep 1982
POSITIVE & NEGATIVE HCG URINE CONTROLS
K821742 · Armkel, LLC · Jul 1982