Cleared Traditional

K780554 - CLIN. CHEM. CONTROL SERUM-QUANTITATE

K780554 is an FDA 510(k) clearance for CLIN. CHEM. CONTROL SERUM-QUANTITATE, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K780554 · Beckman Instruments, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1978
Decision
62d
Days
Class 1
Risk

K780554 is an FDA 510(k) clearance for the CLIN. CHEM. CONTROL SERUM-QUANTITATE. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 6, 1978 after a review of 62 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K780554

510(k) Number K780554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1978
Decision Date June 06, 1978
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 62
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K780554.
P.A.P. RIA CONTROL SERUM PACK
K790985 · Mallinckrodt Critical Care · Jul 1979
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
ISOZYME - ID CPK MARKER
K780801 · Dade, Baxter Travenol Diagnostics, Inc. · Jun 1978
CHEMISTRY CONTROL & REFERENCE SERUMS
K780204 · Hyland Therapeutic Div., Travenol Laboratories · Mar 1978
ISOENZYME SERUM CONTROL
K780147 · Corning Medical & Scientific · Feb 1978
ACA GLUTAMYL TRANSFERASE
K771800 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977