Cleared Traditional

CORDISNHYPERION HEMOGLOBIN A1 TEST SYS (K812242) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K812242 · Cordis Corp. · Hematology device

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Sep 1981

Decision

29d

Days

Class 2

Risk

K812242 is an FDA 510(k) clearance for the CORDISNHYPERION HEMOGLOBIN A1 TEST SYS. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Cordis Corp. (Walker, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - 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 Cordis Corp. devices

Submission Details

510(k) Number	K812242 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 11, 1981
Decision Date	September 09, 1981
Days to Decision	29 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

84d faster than avg

Panel avg: 113d · This submission: 29d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	LCP Assay, Glycosylated Hemoglobin
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 864.7470

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 - LCP Assay, Glycosylated Hemoglobin

All 94

Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K812242.

GLYCO HB QUIK COLUMN PROCEDURE

K823869 · Helena Laboratories · Feb 1983

HEMOGLOBIN ALC BY COLUMN TEST

K822977 · Bio-Rad · Nov 1982

ORTHO* BI-LEVEL ASSAYED GLYCOH. CONTR. S

K811567 · Ortho Diagnostic Systems, Inc. · Sep 1981

BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST

K811710 · Bio-Rad · Jul 1981

LANCER GLYCOSYLATED HEMOGLOBIN

K810638 · Sherwood Medical Co. · May 1981

LANCER GLYCOSYLATED HEMOGLOBIN ASSAY

K810714 · Sherwood Medical Co. · May 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K812242

Cordis Corp.

Walker, MI · US

Regulatory profile

315 submissions 281 cleared

89% clearance rate · Active in Hematology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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