Cleared Traditional

FLAME PHOTOMETER STANDARD (K772153) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K772153 · Alko Scientific Co. · Chemistry device
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Feb 1978
Decision
105d
Days
Class 2
Risk

K772153 is an FDA 510(k) clearance for the FLAME PHOTOMETER STANDARD. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Alko Scientific Co. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1978 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Alko Scientific Co. devices

Submission Details

510(k) Number K772153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1977
Decision Date February 28, 1978
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 79
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K772153.
ACA THYROXINE CALIBRATOR
K833700 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
DUAL COMPONENT STANDARDS
K781423 · Abbott Laboratories · Aug 1978
CALIBRATORS, CARBON DIOXIDE
K780295 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1978
ACA TRIGLYCERIDE CALIBRATOR
K771797 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA CARBON DIOXIDE CALIBRATOR
K771801 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA IRON CALIBRATOR
K771802 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977