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Recognized Consensus Standards

Recognition List Number: 016 Effective Date: 11/03/2006

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 7-4: CLSI / NCCLS GP14-A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline. (InVitro Diagnostics)

Date of Standard: 1996.

Addresses of Standards Organizations:

CLINICAL LABORATORY STANDARDS INSTITUTE (CLSI)

940 WEST VALLEY ROAD

SUITE 1400

WAYNE, PA 19087

NATIONAL COMMITTEE FOR CLINICAL LABORATORY STANDARDS (NCCLS)

940 WEST VALLEY ROAD

SUITE 1400

WAYNE, PA 19087

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)
	DIVISION OF CLINICAL LABORATORY DEVICES (DCLD)

(2)	OFFICE OF COMPLIANCE (OC)

Devices Affected:

Home Use IVD's

Processes Affected:

Manufacturing/Devices Evaluation (510(k), PMA, PDP, IDE)

Type of Standard:

National, Horizontal

Extent of Recognition:

Complete

Related CFR Citations and Product Codes:


CFR §862.1115
Regulation Number	Device Name	Device Class	Product Code
§862.1115	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Class 1	JJB

CFR §862.1155
Regulation Number	Device Name	Device Class	Product Code
§862.1155	Agglutination Method, Human Chorionic Gonadotropin	Class 2	JHJ
§862.1155	Kit, Test, Pregnancy, Hcg, Over The Counter	Class 2	LCX
§862.1155	Radioimmunoassay, Human Chorionic Gonadotropin	Class 2	JHI

CFR §862.1170
Regulation Number	Device Name	Device Class	Product Code
§862.1170	Mercuric Nitrate And Diphenyl Carbazone (Titrimetric), Chloride	Class 2	CHK

CFR §862.1175
Regulation Number	Device Name	Device Class	Product Code
§862.1175	Enzymatic Esterase--Oxidase, Cholesterol	Class 1	CHH

CFR §862.1340
Regulation Number	Device Name	Device Class	Product Code
§862.1340	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Class 2	JIL

CFR §862.1345
Regulation Number	Device Name	Device Class	Product Code
§862.1345	Glucose Oxidase, Glucose	Class 2	CGA
§862.1345	Hexokinase, Glucose	Class 2	CFR

CFR §862.1435
Regulation Number	Device Name	Device Class	Product Code
§862.1435	Nitroprusside, Ketones (Urinary, Non-Quant.)	Class 1	JIN

CFR §862.1485
Regulation Number	Device Name	Device Class	Product Code
§862.1485	Radioimmunoassay, Luteinizing Hormone	Class 1	CEP

CFR §862.1510
Regulation Number	Device Name	Device Class	Product Code
§862.1510	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Class 1	JMT

CFR §862.1550
Regulation Number	Device Name	Device Class	Product Code
§862.1550	Dye-Indicator, Ph (Urinary, Non-Quant.)	Class 1	CEN

CFR §862.1645
Regulation Number	Device Name	Device Class	Product Code
§862.1645	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Class 1	JIR

CFR §862.1785
Regulation Number	Device Name	Device Class	Product Code
§862.1785	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Class 1	CDM

CFR §862.2300
Regulation Number	Device Name	Device Class	Product Code
§862.2300	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Class 1	JJQ

CFR §864.6550
Regulation Number	Device Name	Device Class	Product Code
§864.6550	Blood, Occult, Colorimetric, In Urine	Class 2	JIO
§864.6550	Reagent, Occult Blood	Class 2	KHE

CFR §864.7470
Regulation Number	Device Name	Device Class	Product Code
§864.7470	Assay, Glycosylated Hemoglobin	Class 2	LCP

CFR §866.2900
Regulation Number	Device Name	Device Class	Product Code
§866.2900	Device, Specimen Collection	Class 1	LIO

Relevant Guidance:

Review Criteria for Assessment of Over-The-Counter Human Chorionic Gonadotropin (HCG) In Vitro Diagnostic Devices. Guidance for 510(k)s on Cholesterol Tests for Clinical Laboratory, Physicians Office Laboratories, and Home Use. Points to Consider for Approval of Home Drugs of Abuse Test Kits. Assessing the Safety/Effectiveness of Home-Use In Vitro Diagnostic Devices

FDA Technical Contact:

Arleen Pinkos

FDA/CDRH/OIVD

2098 GAITHER ROAD, HFZ-440

ROCKVILLE MD 20850

240/276-0490

Email: arleen.pinkos@fda.hhs.gov

Database Updated 09/17/2008

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Center for Devices and Radiological Health / CDRH