Cleared Traditional

K860720 - BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)

K860720 is an FDA 510(k) clearance for BIOTRACK MONITOR (BIOTRACK REAGENT CART..., manufactured by Biotrack, Inc.. The device is a Class 1 Hematology device with product code JJQ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K860720 · Biotrack, Inc. · Hematology device
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May 1986
Decision
86d
Days
Class 1
Risk

K860720 is an FDA 510(k) clearance for the BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES). Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Biotrack, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 23, 1986 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2300 - the FDA hematology device 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.

FDA 510(k) Submission Details - K860720

510(k) Number K860720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1986
Decision Date May 23, 1986
Days to Decision 86 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 113d · This submission: 86d
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 257
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K860720.
AKERSCAN COLORIMETRIC ANALYZER
K862908 · Akers Medical Technologies · Sep 1986
ULTRASCAN CLINICAL ANALYZER
K862999 · Specialty Medical Industries, Inc. · Sep 1986
UNISKAN II
K861897 · Flow Laboratories, Inc. · Jul 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · Pharmacia, Inc. · May 1986
MINI-CHEM ANALYZER
K860987 · Ocean Scientific, Inc. · May 1986
THE JR. PARTNER SPECTROPHOTOMETER
K861223 · Pharmacia, Inc. · May 1986
K860720 · BIOTRACK MONITOR (BIOTRACK REAGENT CARTRIDGES)
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