Cleared Traditional

K895102 - BIOTRACK PDS MONITOR

K895102 is the FDA 510(k) clearance for BIOTRACK PDS MONITOR by Biotrack, Inc.. It is a Class 1 Hematology device (product code JJQ) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K895102 · Biotrack, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
56d
Days
Class 1
Risk

K895102 is an FDA 510(k) clearance for the BIOTRACK PDS MONITOR. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 10, 1989 after a review of 56 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.

View all Biotrack, Inc. devices

Submission Details

510(k) Number K895102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date October 10, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 135
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K895102.
COBAS READY
K896007 · Roche Diagnostic Systems, Inc. · Dec 1989
LP 400 MICROPLATE READER
K894859 · Kallestad Diag, A Div. of Erbamont, Inc. · Oct 1989
MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER
K895313 · Dynatech Laboratories, Inc. · Oct 1989
DYNATECH MR 5000, CATALOG #011-976-0600
K894687 · Dynatech Laboratories, Inc. · Aug 1989
QUIDEL REFLECTANCE ANALYZER
K893738 · Quidel Corp. · Aug 1989
MICROTRAK EIA AUTOREADER
K891270 · Syva Co. · Jun 1989