Cleared Traditional

K962410 - N PROTEIN STANDARD PY

K962410 is the FDA 510(k) clearance for N PROTEIN STANDARD PY by Behring Diagnostics, Inc.. It is a Class 2 Hematology device (product code JIX) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K962410 · Behring Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
25d
Days
Class 2
Risk

K962410 is an FDA 510(k) clearance for the N PROTEIN STANDARD PY. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on July 16, 1996 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1150 - 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K962410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1996
Decision Date July 16, 1996
Days to Decision 25 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIX Calibrator, Multi-analyte Mixture

All 201
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K962410.
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
K963533 · Sigma Diagnostics, Inc. · Oct 1996
DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
K962629 · Casco Standards · Sep 1996
N CRP STANDARD SY
K962406 · Behring Diagnostics, Inc. · Jul 1996
CALIBRATION SERUM LEVEL 1 & 2
K955489 · Randox Laboratories, Ltd. · Jun 1996
CEDIA CORE TDM MULTI-CAL
K961659 · Boehringer Mannheim Corp. · Jun 1996
APOLIPOPROTEIN CALIBRATOR (APO-CAL)
K953979 · Beckman Instruments, Inc. · Oct 1995