K172512 · Acro Biotech, Inc. · LCX · Feb 2, 2018 · Clinical Chemistry
Device Facts
Record ID
K172512
Device Name
ACRO HCG Pregnancy Rapid Test
Applicant
Acro Biotech, Inc.
Product Code
LCX · Clinical Chemistry
Decision Date
Feb 2, 2018
Decision
SESE
Submission Type
Special
Regulation
21 CFR 862.1155
Device Class
Class 2
Indications for Use
The ACRO hCG Pregnancy Rapid Test is used by the consumer for the visual qualitative detection of Human Chorionic Gonadotropin (hCG) in urine. It is used to detect the pregnancy of HCG in urine as an indication of pregnancy.
Device Story
Lateral flow immunoassay for qualitative hCG detection in urine; modified version of MiniStick Pregnancy Test (k960733). Modifications include: addition of absorbent sample application tip; updated storage conditions (35-86°F); adjusted read time (3-10 minutes); renamed to ACRO HCG Pregnancy Rapid Test. Device used for point-of-care or home pregnancy testing. User applies urine sample to absorbent tip; hCG presence indicated by visual color change on test strip. Results assist in pregnancy confirmation.
Clinical Evidence
Bench testing only; design control activities and risk analysis performed to validate modifications.
Technological Characteristics
Lateral flow sandwich immunochromatographic assay. Components include nitrocellulose membrane, colloidal gold conjugate pad, and sample pad. Uses monoclonal hCG antibodies. Form factor is a midstream test strip in plastic housing with optional absorbent tip. Qualitative visual readout. Traceable to WHO 4th International Standard.
Indications for Use
Indicated for the qualitative detection of human chorionic gonadotropin (hCG) in urine for 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.
Predicate Devices
MiniStick Pregnancy Test (k960733)
Submission Summary (Full Text)
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SPECIAL 510(k): Device Modification OIR Decision Summary
To: THE FILE
RE: DOCUMENT NUMBER k172512
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):
1. The name and 510(k) number of the SUBMITTER'S previously cleared device: k960733, MiniStick Pregnancy Test
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.
This change is for following:
- Change to the recommended device storage conditions from below 86°F (30 °C) to 35-86°F (2-30°C)
- Addition of an absorbent sample application tip.
- Change to the recommended device read time from 5 minutes to between 3 to 10 minutes
- Change to the device trade name to ACRO HCG Pregnancy Rapid Test
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics.
5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New
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510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
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