Cleared Traditional

K812220 - NEPHELOMETRIC SOLID TURBIDITY STANDARD

K812220 is the FDA 510(k) clearance for NEPHELOMETRIC SOLID TURBIDITY STANDARD by Hyland Therapeutic Div., Travenol Laboratories. It is a Class 2 Immunology device (product code JIW) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K812220 · Hyland Therapeutic Div., Travenol Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
12d
Days
Class 2
Risk

K812220 is an FDA 510(k) clearance for the NEPHELOMETRIC SOLID TURBIDITY STANDARD. Classified as Calibrator, Surrogate (product code JIW), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 18, 1981 after a review of 12 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 Hyland Therapeutic Div., Travenol Laboratories devices

Submission Details

510(k) Number K812220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1981
Decision Date August 18, 1981
Days to Decision 12 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
92d faster than avg
Panel avg: 104d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIW Calibrator, Surrogate
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 - JIW Calibrator, Surrogate

All 12
Devices cleared under the same product code (JIW) and FDA review panel - the closest regulatory comparables to K812220.
CALIBRATION KIT
K882220 · King Diagnostics, Inc. · Aug 1988
AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200
K880654 · American Research Products Co. · Jun 1988
UNIMETER CALIBRATION KIT
K880610 · Boehringer Mannheim Corp. · Mar 1988
DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)
K801300 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1980
CENTRIFICHEM FILTER CALIBRATION SET
K800304 · Union Carbide Corp. · Mar 1980
CENTRIFICHEM FILTER CALIBRATION SET
K790643 · Union Carbide Corp. · May 1979