Atellica IM Total hCG (ThCG)

K192790 · Siemens Healthcare Diagnostics, Inc. · DHA · Oct 30, 2019 · Clinical Chemistry

Device Facts

• Record ID: K192790
• Device Name: Atellica IM Total hCG (ThCG)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: DHA · Clinical Chemistry
• Decision Date: Oct 30, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

The Atellica® IM Total hCG (ThCG) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hCG) in human serum or plasma (EDTA or lithium heparin) using the Atellica® IM Analyzer. Human chorionic gonadotropin measurements are intended for use as an aid in the early detection of pregnancy.

Device Story

The Atellica® IM Total hCG (ThCG) assay is an in vitro diagnostic test used on the Atellica® IM Analyzer to quantitatively measure human chorionic gonadotropin (hCG) in human serum or plasma. The device utilizes a sandwich immunoassay principle with direct chemiluminescent technology. It employs a goat polyclonal anti-hCG antibody labeled with acridinium ester and a mouse monoclonal anti-hCG antibody coupled to paramagnetic particles. The analyzer processes samples to produce a quantitative result, which clinicians use as an aid in the early detection of pregnancy. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Specimen equivalency was evaluated by comparing serum to EDTA and lithium heparin plasma samples using Deming linear regression (N=116 for EDTA, N=134 for lithium heparin). Results showed high correlation (r=1.00) with slopes of 1.02 and 1.05, respectively. Interference testing per CLSI EP07-ed3 confirmed minimal bias (<2%) for both anticoagulants at tested concentrations.

Technological Characteristics

Sandwich immunoassay; direct chemiluminescent technology. Reagents: Goat polyclonal anti-hCG antibody labeled with acridinium ester; mouse monoclonal anti-hCG antibody on paramagnetic particles. Standardized against WHO 4th IS 75/589. Assay range: 2.6–1000 mIU/mL. Incubation: 8 minutes at 37°C. Sample volume: 25 µL. Automated system (Atellica IM Analyzer).

Indications for Use

Indicated for the quantitative determination of hCG in human serum or plasma (EDTA or lithium heparin) as an aid in the early detection of pregnancy.

Regulatory Classification

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. 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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k192790

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.