Product Code: JIW FDA class 2 21 CFR 862.1150

Calibrator, Surrogate

Clinical Chemistry

This device is a surrogate calibrator used in clinical chemistry analyzers, providing matrix-matched reference material that approximates the behavior of patient samples during instrument calibration when authentic human primary standards are not available or practical. It is classified as FDA Class 2, subject to moderate regulatory oversight and requiring 510(k) premarket notification. The product code is JIW, regulated under 21 CFR 862.1150, within the Clinical Chemistry medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JIW
Device Class: FDA class 2
Regulation Number: 862.1150
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 17 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K973055	WAKO CH50 LINEARITY SET	Sep 25, 1997	Substantially Equivalent	Wako Chemicals USA, Inc.
K970396	HUMAN CHORIONIC GONADOTROPIN CALIBRATOR	Feb 20, 1997	Substantially Equivalent	Dade Chemistry Systems, Inc.
K910255	FLOW CYTOMETRY FITC/PE COMPENSATION KIT	Apr 03, 1991	Substantially Equivalent	Sigma Diagnostics, Inc.
K902575	SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL)	Oct 04, 1990	Substantially Equivalent	Diagnostic Products Corp.
K902294	ACCUSCAN MICROBEAD STANDARDS	Jul 03, 1990	Substantially Equivalent	Sigma Chemical Co.
K892213	ACS COLLOID OSMOTIC PRESSURE CALIBRATOR	Jun 21, 1989	Substantially Equivalent	Analytical Control Systems, Inc.
K883389	RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD	Dec 14, 1988	Substantially Equivalent	Reagents Applications, Inc.
K882220	CALIBRATION KIT	Aug 02, 1988	Substantially Equivalent	King Diagnostics, Inc.
K880654	AMRESCO LIQUIZYME GLUCOSE/BUN STANDARD 0124, 0200	Jun 07, 1988	Substantially Equivalent	American Research Products Co.
K880610	UNIMETER CALIBRATION KIT	Mar 24, 1988	Substantially Equivalent	Boehringer Mannheim Corp.
K854028	AUDIT AUTOMATED BLOOD CHEMISTRY ANALYZER	Dec 02, 1985	Substantially Equivalent	Verified Medical Research, Inc.
K851450	FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM	Sep 16, 1985	Substantially Equivalent	Flow Cytometry Standards Corp.
K852260	QUICK-CHEM CALIBRATION SET	Jul 22, 1985	Substantially Equivalent	Seragen Diagnostics, Inc.
K812220	NEPHELOMETRIC SOLID TURBIDITY STANDARD	Aug 18, 1981	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories
K801300	DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL)	Jul 08, 1980	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K800304	CENTRIFICHEM FILTER CALIBRATION SET	Mar 12, 1980	Substantially Equivalent	Union Carbide Corp.
K790643	CENTRIFICHEM FILTER CALIBRATION SET	May 23, 1979	Substantially Equivalent	Union Carbide Corp.