(62 days)
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No
The summary describes a qualitative immunoassay with on-board controls and a concordance study, with no mention of AI, ML, or image processing.
No.
The device is for the qualitative determination of human chorionic gonadotropin in serum or urine, which is a diagnostic function, not a therapeutic one. It provides information for diagnosis but does not treat or cure a disease or condition.
Yes
The device is used for the "qualitative determination of human chorionic gonadotropin in serum or urine," which is a diagnostic purpose to detect the presence of hCG for pregnancy testing.
No
The device description clearly indicates it is a physical assay (ABBOTT TestPack Plus hCG COMBO with OBC assay) that incorporates on-board controls, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "the qualitative determination of human chorionic gonadotropin in serum or urine." This clearly indicates that the device is used to test samples taken from the human body (serum or urine) in vitro (outside the body) to diagnose or provide information about a physiological state (pregnancy, in this case, as hCG is a marker for pregnancy).
- Device Description: The description mentions "assays," which are laboratory tests performed on biological samples.
- Performance Studies: The performance studies describe testing "serum specimens and urine specimens," further confirming the use of biological samples in vitro.
These points are all characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of both assays is the qualitative determination of human chorionic gonadotropin in serum or urine.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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