Cleared Traditional

K944788 - INTACT PTH IMMUNORADIOMETRIC (IRMA) ASS...

K944788 is an FDA 510(k) clearance for INTACT PTH IMMUNORADIOMETRIC (IRMA) ASS..., manufactured by Scantibodies Laboratory, Inc.. The device is a Class 2 Chemistry device with product code CEW cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K944788 · Scantibodies Laboratory, Inc. · Chemistry device
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Jul 1995
Decision
294d
Days
Class 2
Risk

K944788 is an FDA 510(k) clearance for the INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY). Classified as Radioimmunoassay, Parathyroid Hormone (product code CEW), Class II - Special Controls.

Submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on July 19, 1995 after a review of 294 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1545 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Scantibodies Laboratory, Inc. devices

FDA 510(k) Submission Details - K944788

510(k) Number K944788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1994
Decision Date July 19, 1995
Days to Decision 294 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 88d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEW Device Classification - Class 2, Special Controls

Product Code CEW Radioimmunoassay, Parathyroid Hormone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1545
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 Chemistry devices follow this clearance model.

Regulatory Peers - CEW Radioimmunoassay, Parathyroid Hormone

All 72
Devices cleared under the same product code (CEW) and FDA review panel - the closest regulatory comparables to K944788.
NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT
K962598 · Nichols Institute Diagnostics · Dec 1996
CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT
K962033 · Nichols Institute Diagnostics · Sep 1996
INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION)
K954418 · Nichols Institute Diagnostics · Nov 1995
ACTIVE INTACT PTH ELISA
K952199 · Diagnostic Systems Laboratories, Inc. · Jul 1995
GAMMA-BCT INTACT PTH
K942369 · Immunodiagnostic Systems , Ltd. · Sep 1994
IMMUNLITE INTACT PTH
K934760 · Diagnostic Products Corp. · Dec 1993