Cleared Traditional

PLAN A LIFE (K830975) - FDA 510(k) Clearance

Class I Chemistry device.

K830975 · New Directions Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
40d
Days
Class 1
Risk

K830975 is an FDA 510(k) clearance for the PLAN A LIFE. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General Controls.

Submitted by New Directions Co. (Mchenry, US). The FDA issued a Cleared decision on May 4, 1983 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1435 - 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 New Directions Co. devices

Submission Details

510(k) Number K830975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1983
Decision Date May 04, 1983
Days to Decision 40 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
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 - JIN Nitroprusside, Ketones (urinary, Non-quant.)

All 10
Devices cleared under the same product code (JIN) and FDA review panel - the closest regulatory comparables to K830975.
On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis
K170587 · ACON Laboratories, Inc. · Jul 2017
ABBOTT BREATH ACETONE ANALYZER
K875029 · Abbott Laboratories · May 1988
SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV
K850368 · Sigma Chemical Co. · Aug 1985
HELENA BIOSTRIP K
K830976 · Helena Laboratories · May 1983
TEST FOR KETONE IN URINE(ACETOACETIC AC
K801270 · Miles Laboratories, Inc. · Jul 1980