Cleared Traditional

K792013 - LANCER L-INA HUMAN REFERENCE SERUM

K792013 is an FDA 510(k) clearance for LANCER L-INA HUMAN REFERENCE SERUM, manufactured by Sherwood Medical Industries. The device is a Class 2 Immunology device with product code JIX cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K792013 · Sherwood Medical Industries · Immunology device
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Nov 1979
Decision
39d
Days
Class 2
Risk

K792013 is an FDA 510(k) clearance for the LANCER L-INA HUMAN REFERENCE SERUM. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1150 - the FDA immunology 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 Sherwood Medical Industries devices

FDA 510(k) Submission Details - K792013

510(k) Number K792013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1979
Decision Date November 13, 1979
Days to Decision 39 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 105d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIX Device Classification - Class 2, Special Controls

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 Immunology devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 272
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K792013.
SERACON-SRI (PROD. # D029
K792486 · Bhp Diagnostix, Inc. · Dec 1979
SERACON-SRII
K792487 · Bhp Diagnostix, Inc. · Dec 1979
PRINCIPAL ANALYTE REFERENCE SERUM
K792384 · Beckman Instruments, Inc. · Dec 1979
CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD
K791874 · Gilford Diagnostics · Oct 1979
SERACON CAL D025
K791956 · Bhp Diagnostix, Inc. · Oct 1979
CALIBRATOR I
K791693 · Hi Chem, Inc. · Sep 1979