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510(k) Data Aggregation
(113 days)
STANDARD DIAGNOSTICS, INC.
SmartLink™ GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink™ GOLD meter must be used with SmartLink™ GOLD blood glucose test strip and SD Control solutions.
The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in · clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
The SmartLink™ GOLD Blood Glucose System is an Rx/OTC blood glucose system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.
The SmartLink™ GOLD Blood Glucose System consists of a SmartLink™ GOLD Blood Glucose Meter which measures and displays test results, SmartLink™ GOLD test strip, lancet and lancing device for blood sampling, control solution to check the meter and test strip, check strip to check the meter, 3 V battery (type 2032) for power, carrying case, user guide, packaging inserts for the test strip and control solution and a Quick Guide for helping the user with a self test diary to document test results for monitoring the trend of blood glucose.
The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The svstem can also set the pre-meal and postmeal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document references compliance with EN ISO 15197:2003. This standard outlines specific accuracy criteria for blood glucose monitoring systems. While the exact numerical criteria from the standard are not explicitly listed in this document, the submission confirms that the device "met all relevant standards requirements" (Page 3).
| Acceptance Criteria (Based on EN ISO 15197:2003, typically) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document, but for lay-user operated blood glucose systems, EN ISO 15197:2003 generally requires: |
- 95% of results to be within ±15 mg/dL of the reference method for glucose concentrations
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(449 days)
STANDARD DIAGNOSTICS, INC.
SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions.
The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing newborns.
SD CHECK GOLD blood glucose system is applicable to monitor blood glucose in capillary whole blood.
SD CHECK GOLD blood glucose monitoring system is comprised of the following.
- SD CHECK GOLD blood glucose meter
- SD CHECK GOLD blood glucose test strip i
- SD CHECK GOLD control solution -
- i SD CHECK GOLD check strip
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
I am sorry, but the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance. The document is a 510(k) summary for the SD CHECK GOLD blood glucose monitoring system, declaring its substantial equivalence to predicate devices, but it does not include the results of clinical performance studies with specific statistical metrics, sample sizes, or details about ground truth establishment.
Therefore, I cannot generate the table of acceptance criteria and reported device performance or answer questions 2 through 9 based on the given input.
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(155 days)
STANDARD DIAGNOSTICS, INC.
The Good Morning Test kit is a qualitative chromatographic immunoassay, which determines whether a woman is pregnant or not by identifying the presence of hCG in urine.
The Good Morning Test kit is a qualitative chromatographic immunoassay
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Standard Diagnostics, Inc. Good Morning Test" for Human Chorionic Gonadotropin (HCG). This document does not contain the detailed study information required to answer the questions about acceptance criteria, performance data, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device's clearance is based on substantial equivalence to an existing device, not necessarily on a new full clinical trial detailed within this document.
Therefore, I cannot provide the requested information from the given text. A 510(k) submission summary or the full submission itself would be needed to extract this level of detail about the device's performance study.
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