Cleared Traditional

K781573 - ABNORMAL HEMATOLOGY CONTROL UNASSAYED

K781573 is an FDA 510(k) clearance for ABNORMAL HEMATOLOGY CONTROL UNASSAYED, manufactured by Ortho Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K781573 · Ortho Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1978
Decision
33d
Days
Class 2
Risk

K781573 is an FDA 510(k) clearance for the ABNORMAL HEMATOLOGY CONTROL UNASSAYED. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1978 after a review of 33 days - a notably fast clearance 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: 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 Ortho Diagnostics, Inc. devices

FDA 510(k) Submission Details - K781573

510(k) Number K781573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1978
Decision Date October 17, 1978
Days to Decision 33 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
80d faster than avg
Panel avg: 113d · This submission: 33d
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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K781573.
QUANTICEL HHR, L531 AND L532
K781745 · Bhp Diagnostix, Inc. · Nov 1978
QUANTICEL HHR # L500 AND L501
K781786 · Bhp Diagnostix, Inc. · Nov 1978
NORMAL HEMATOLOGY CONTROL UNASSAYED
K781572 · Ortho Diagnostics, Inc. · Oct 1978
QUANTICEL-HRP
K781247 · Bhp Diagnostix, Inc. · Sep 1978
PLATELET CONTROL
K780980 · Bhp Diagnostix, Inc. · Jul 1978
CONTROL, HEMATOLOGY, CH-60
K781077 · Dade, Baxter Travenol Diagnostics, Inc. · Jul 1978