Cleared Traditional

K841809 - COUNT-A-PART PLUS

K841809 is an FDA 510(k) clearance for COUNT-A-PART PLUS, manufactured by Diagnostic Technology, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K841809 · Diagnostic Technology, Inc. · Hematology device
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Nov 1984
Decision
213d
Days
Class 2
Risk

K841809 is an FDA 510(k) clearance for the COUNT-A-PART PLUS. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on November 30, 1984 after a review of 213 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Technology, Inc. devices

FDA 510(k) Submission Details - K841809

510(k) Number K841809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date November 30, 1984
Days to Decision 213 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
100d slower than avg
Panel avg: 113d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JPK Mixture, Hematology Quality Control

All 160
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K841809.
QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
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K844928 · Bhp Diagnostix, Inc. · Mar 1985
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
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RETIC-CHEX
K843093 · Streck Laboratories, Inc. · Oct 1984
PARA-TEK
K841531 · Streck Laboratories, Inc. · Jul 1984