Cleared Traditional

K982217 - AC/AD LINEARITY VERIFIERS

K982217 is an FDA 510(k) clearance for AC/AD LINEARITY VERIFIERS, manufactured by Sc Calibrators & Controls, LLC. The device is a Class 1 Toxicology device with product code DIF cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K982217 · Sc Calibrators & Controls, LLC · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
8d
Days
Class 1
Risk

K982217 is an FDA 510(k) clearance for the AC/AD LINEARITY VERIFIERS. Classified as Drug Mixture Control Materials (product code DIF), Class I - General Controls.

Submitted by Sc Calibrators & Controls, LLC (Santa Monica, US). The FDA issued a Cleared decision on July 2, 1998 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - 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: 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 Sc Calibrators & Controls, LLC devices

FDA 510(k) Submission Details - K982217

510(k) Number K982217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1998
Decision Date July 02, 1998
Days to Decision 8 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 87d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

DIF Device Classification - Class 1, General Controls

Product Code DIF Drug Mixture Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
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 Consultant

Tuv Product Service, Inc.
CAROLE STAMP

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DIF Drug Mixture Control Materials

All 175
Devices cleared under the same product code (DIF) and FDA review panel - the closest regulatory comparables to K982217.
ONTRAK TESTCUP AND TESTSTIK CONTROLS
K983387 · Roche Diagnostic Systems, Inc. · Oct 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
K983127 · Medical Analysis Systems, Inc. · Sep 1998
VITROS CHEMISTRY PRODUCTS TDM PERFORMANCE VERIFIERS I, II, AND III
K982649 · Ortho-Clinical Diagnostics, Inc. · Aug 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · Medical Analysis Systems, Inc. · Jun 1998
LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON
K981590 · Bio-Rad · Jun 1998
LYPHOCHEK WHOLE BLOOD CONTROL
K980871 · Bio-Rad · Apr 1998