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K Number
K990222
Device Name
IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
1999-02-26

(32 days)

Product Code
DHA
Regulation Number
862.1155
Type
Traditional
Panel
CH
Reference & Predicate Devices
K911796
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

IMMULITE HCG: For in vitro diagnostic use with the IMMULITE analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.

IMMULITE 2000 HCG: For in vitro diagnostic use with the IMMULITE 2000 analyzer - for quantitative measurement of human chorionic gonadotropin (HCG) in serum, and for strictly qualitative determinations in urine, as an aid in the detection of pregnancy.

Device Description

IMMULITE HCG is a clinical use device intended for use with the IMMULITE Automated Immunoassay Analyzer.

IMMULITE 2000 HCG is a clinical use device intended for use with the IMMULITE 2000 Automated Immunoassay Analyzer.

AI/ML Overview

This document is a 510(k) summary for the IMMULITE HCG and IMMULITE 2000 HCG reagent systems. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The provided text details:

  • Device identification: IMMULITE HCG and IMMULITE 2000 HCG.
  • Manufacturer and importer information.
  • Predicate devices: IMMULITE HCG (K911796) and IMMULITE 2000 HCG (K911796).
  • Description of devices: Clinical use devices for use with specific automated immunoassay analyzers.
  • Intended Use: Quantitative measurement of human chorionic gonadotropin (HCG) in serum and qualitative determinations in urine for pregnancy detection.
  • FDA Clearance: A letter from the FDA confirming substantial equivalence to predicate devices and allowing marketing.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the given text. This document focuses on regulatory clearance based on substantial equivalence to existing devices, not on the detailed performance studies that would typically define and test against specific acceptance criteria.

§ 862.1155 Human chorionic gonadotropin (HCG) test system.

(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.