Cleared Traditional

K881458 - ASTROSCAN 2100 MICROTITER PLATE READER

K881458 is the FDA 510(k) clearance for ASTROSCAN 2100 MICROTITER PLATE READER by Astroscan , Ltd.. It is a Class 1 Hematology device (product code JJQ) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K881458 · Astroscan , Ltd. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
83d
Days
Class 1
Risk

K881458 is an FDA 510(k) clearance for the ASTROSCAN 2100 MICROTITER PLATE READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Astroscan , Ltd. (Biritish Isles, England, GB). The FDA issued a Cleared decision on June 29, 1988 after a review of 83 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 Astroscan , Ltd. devices

Submission Details

510(k) Number K881458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1988
Decision Date June 29, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 113d · This submission: 83d
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 K881458.
BEHRING TURBITIMER
K883646 · Behring Diagnostics, Inc. · Oct 1988
NOVASPEC II SPECTROPHOTOMETER
K883435 · Pharmacia, Inc. · Oct 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · Behring Diagnostics, Inc. · Aug 1988
COBAS EIA(TM) PHOTOMETER
K881877 · Roche Diagnostic Systems, Inc. · Jun 1988
CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA
K873384 · Helena Laboratories · Nov 1987
DYNATECH MR 300 MANUAL MICROELISA
K874244 · Dynatech Laboratories, Inc. · Nov 1987