Cleared Traditional

K973791 - ABC CALIBRATION VERIFIERS

K973791 is an FDA 510(k) clearance for ABC CALIBRATION VERIFIERS, manufactured by Sc Calibrators & Controls, LLC. The device is a Class 1 Chemistry device with product code JJY cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K973791 · Sc Calibrators & Controls, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
8d
Days
Class 1
Risk

K973791 is an FDA 510(k) clearance for the ABC CALIBRATION VERIFIERS. Classified as Multi-analyte Controls, All Kinds (assayed) (product code JJY), Class I - General Controls.

Submitted by Sc Calibrators & Controls, LLC (Santa Monica, US). The FDA issued a Cleared decision on October 14, 1997 after a review of 8 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 Sc Calibrators & Controls, LLC devices

FDA 510(k) Submission Details - K973791

510(k) Number K973791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date October 14, 1997
Days to Decision 8 days
Submission Type Traditional
Review Panel Chemistry (CH)
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
80d faster than avg
Panel avg: 88d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

JJY Device Classification - Class 1, General Controls

Product Code JJY Multi-analyte Controls, All Kinds (assayed)
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 Consultant

Tuv Product Service, Inc.

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 - JJY Multi-analyte Controls, All Kinds (assayed)

All 594
Devices cleared under the same product code (JJY) and FDA review panel - the closest regulatory comparables to K973791.
ELECSYS CALCHECK FOLATE
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IMMUSURE
K973894 · Quantimetrix Corp. · Oct 1997
ABC LINEARITY VERIFIERS
K973790 · Sc Calibrators & Controls, LLC · Oct 1997
PRECINORM RF, PRECIPATH RF
K973629 · Boehringer Mannheim Corp. · Oct 1997
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
K973469 · Consolidated Technologies, Inc. · Sep 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K973517 · Johnson & Johnson Clinical Diagnostics, Inc. · Sep 1997