Cleared Traditional

K833977 - SERALYZER DRUG ASSAY CONTROL SERUM

K833977 is an FDA 510(k) clearance for SERALYZER DRUG ASSAY CONTROL SERUM, manufactured by Miles Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DLJ cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K833977 · Miles Laboratories, Inc. · Toxicology device
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Mar 1984
Decision
123d
Days
Class 2
Risk

K833977 is an FDA 510(k) clearance for the SERALYZER DRUG ASSAY CONTROL SERUM. Classified as Calibrators, Drug Specific (product code DLJ), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3200 - the FDA toxicology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K833977

510(k) Number K833977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1983
Decision Date March 19, 1984
Days to Decision 123 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 87d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DLJ Device Classification - Class 2, Special Controls

Product Code DLJ Calibrators, Drug Specific
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3200
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 Toxicology devices follow this clearance model.

Regulatory Peers - DLJ Calibrators, Drug Specific

All 110
Devices cleared under the same product code (DLJ) and FDA review panel - the closest regulatory comparables to K833977.
DUPONT THEOPHYLLINE DIT CALIBRATOR
K841655 · E.I. Dupont DE Nemours & Co., Inc. · May 1984
ACA DIGOXIN CALLIBRATOR
K841108 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1984
QUINIDINE CALIBRATOR
K840597 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1984
LIDOAINE CALIBRATOR
K833380 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
VALPROIC ACID CALIBRATOR
K833382 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
PROCAINAMIDE CALIBRATOR
K833383 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983