Cleared Traditional

K872219 - GEN-PROBE LUMINOMETER - LEADER (TM)

K872219 is an FDA 510(k) clearance for GEN-PROBE LUMINOMETER - LEADER (TM), manufactured by Gen-Probe, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K872219 · Gen-Probe, Inc. · Chemistry device
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Aug 1987
Decision
70d
Days
Class 1
Risk

K872219 is an FDA 510(k) clearance for the GEN-PROBE (R) LUMINOMETER - LEADER (TM). Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on August 21, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Gen-Probe, Inc. devices

FDA 510(k) Submission Details - K872219

510(k) Number K872219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1987
Decision Date August 21, 1987
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 150
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K872219.
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
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DYNATECH MR 300 MANUAL MICROELISA
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MODEL 690 SPECTROPHOTOMETER
K873408 · Abbott Diagnostics · Sep 1987
SYVA Q-SPEC PHOTOMETER
K871307 · Syva Co. · May 1987
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · Ciba Corning Diagnostics Corp. · May 1987
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)
K871415 · Dynatech Laboratories, Inc. · Apr 1987