ABBOTT TESTPACK PLUS HCG COMBO WITH OBC

K965116 · Abbott Laboratories · JHI · Feb 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965116
• Device Name: ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
• Applicant: Abbott Laboratories
• Product Code: JHI · Clinical Chemistry
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Intended Use

The intended use of both assays is the qualitative determination of human chorionic gonadotropin in serum or urine.

Device Story

In-vitro diagnostic immunoassay; detects human chorionic gonadotropin (hCG) in serum or urine samples; utilizes plus/minus visual indicator; incorporates On Board Controls (OBC) providing positive (√) and negative (X) procedural verification; used in clinical settings; provides qualitative results (positive/negative) at threshold of 25 mIU/mL or greater; assists healthcare providers in pregnancy diagnosis.

Clinical Evidence

Concordance study comparing subject device to predicate; 1085 serum specimens and 934 urine specimens tested; 100% concordance observed for both sample types.

Technological Characteristics

Qualitative immunoassay; visual plus/minus indicator; includes integrated On Board Controls (POS CTL √, NEG CTL X); sensitivity threshold 25 mIU/mL; manual test format.

Indications for Use

Indicated for qualitative determination of human chorionic gonadotropin (hCG) in serum or urine specimens to aid in the detection of pregnancy. No specific age or gender restrictions provided.

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.

Predicate Devices

• ABBOTT TestPack Plus hCG COMBO (List No. 3A60)

Submission Summary (Full Text)

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K965116
510(k) Summary
FEB 20 1997

# Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification [510(k) for ABBOTT TestPack® Plus™ hCG COMBO with OBC®] constitutes data supporting a substantially equivalent determination. ABBOTT TestPack Plus hCG COMBO with OBC (List No. 7B34) is substantially equivalent to ABBOTT TestPack® Plus™ hCG COMBO (List No. 3A60).

Substantial equivalence has been demonstrated between the ABBOTT TestPack Plus hCG COMBO with OBC assay and the ABBOTT TestPack Plus hCG COMBO assay. The intended use of both assays is the qualitative determination of human chorionic gonadotropin in serum or urine. A concordance analysis between the two assays, using 1085 serum specimens and 934 urine specimens, yielded a concordance of 100% for serum specimens and a concordance of 100% for urine specimens.

Both the ABBOTT TestPack Plus hCG COMBO with OBC assay and the ABBOTT TestPack Plus hCG COMBO assay measure hCG levels of 25 mIU/mL or greater.

While both assays utilize a plus/minus indicator, the ABBOTT TestPack Plus hCG COMBO with OBC assay incorporates additional On Board Controls: POS CTL (√) and NEG CTL (X).

In conclusion, these data demonstrate that ABBOTT TestPack Plus hCG COMBO with OBC (List No. 7B34) is safe and effective and is substantially equivalent to ABBOTT TestPack Plus hCG COMBO (List No. 3A60).

Prepared and Submitted December 19, 1996 by:

Abbott Laboratories
Karen L. Gates
Regulatory Specialist
ADD Regulatory Affairs
Abbott Park, Illinois 60064-3500

Abbott TestPack Plus hCG COMBO with OBC
December, 1996
hog510b
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