(25 days)
Not Found
No
The description focuses on a standard electrochemical biosensor technology for glucose measurement and does not mention any AI or ML components.
No
The device is an in vitro diagnostic (IVD) device used for measuring glucose levels, which aids in diagnosis and monitoring, rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states "in vitro diagnostic, multiple-patient use for the quantitative determination of glucose".
No
The device description explicitly states the system consists of a hand held meter, test strips, control solutions, and linearity solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, multiple-patient use for the quantitative determination of glucose..."
- In Vitro Nature: The device analyzes biological specimens (blood) outside of the body ("in vitro").
- Diagnostic Purpose: The device is used for the "quantitative determination of glucose," which is a diagnostic measurement used to assess a patient's glucose levels and determine dysglycemia.
The description of the device and its function further supports its classification as an IVD, as it involves the use of reagents and a meter to analyze a biological sample for a diagnostic purpose.
N/A
Intended Use / Indications for Use
The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.
Product codes (comma separated list FDA assigned to the subject device)
PZI, CGA
Device Description
The Nova Biomedical StatStrip Xpress 2 Glucose Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The test strip contains a reagent (glucose oxidase) that reacts with the glucose in the test sample is applied to the test strip, which is then analyzed in the meter. The reagent test strip contains glucose oxidase and glucose dehydrogenase, which reacts with the glucose in the test sample.
A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. When enough sample has been added to the strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 6 seconds. The system is designed for hospital point of care (POC) use including physicians' office labs.
Test Strips:
The StatStrip Glucose Test Strip is designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood.
The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Test strips will be sold in vials of 50 strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital point of care (POC) use including physicians' office labs.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
March 1, 2019
Nova Biomedical Corporation Paul MacDonald Senior Director of Regulatory Affairs 200 Prospect Street Waltham, MA 02454
Re: K163490
Trade/Device Name: StatStrip Xpress 2 Glucose Hospital Meter System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: PZI Dated: December 9, 2016 Received: December 12, 2016
Dear Paul MacDonald:
This letter corrects our substantially equivalent letter of January 6, 2017.
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 to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name StatStrip Xpress 2 Glucose Hospital Meter System
Indications for Use (Describe)
The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, neonate arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary
| 510(K) Owner: | Nova Biomedical Corporation |
|---|---|
| Registration Number: | 1219029 |
| Address: | 200 Prospect St. |
| Waltham, MA 02454 | |
| Phone: | 781-894-0800 |
| Fax Number: | 784-891-4806 |
| Contact Person: | Paul W. MacDonald |
| Date Prepared: | December 9, 2016 |
Proprietary Name: StatStrip Xpress 2 Glucose Hospital Meter System
Common or Usual Name: Blood Glucose Meter
Classification Name:
| Classification Names: | Class No. | Reg. No. | Class |
|---|---|---|---|
| Glucose Oxidase | 75CGA | 862.1345 | II |
Product Codes: CGA, Glucose Oxidase, Glucose
Predicate Device: K152986 - StatStrip Xpress 2 Glucose Hospital Meter System
Device Description:
The Nova Biomedical StatStrip Xpress 2 Glucose Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The test strip contains a reagent (glucose oxidase) that reacts with the glucose in the test sample is applied to the test strip, which is then analyzed in the meter. The reagent test strip contains glucose oxidase and glucose dehydrogenase, which reacts with the glucose in the test sample.
A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. When enough sample has been added to the strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 6 seconds. The system is designed for hospital point of care (POC) use including physicians' office labs.
Test Strips:
The StatStrip Glucose Test Strip is designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood.
The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Test strips will be sold in vials of 50 strips.
Intended Use:
The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens.
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The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings.
The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.
Summary of the Technological Characteristics:
The StatStrip Xpress 2 Glucose Hospital Meter System is substantially equivalent to the predicate device. The modification of the lower limit of the operating temperature range from 15°C to 5°C does not adversely affect the safety or efficacy of the device.
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| Characteristic | Predicate: StatStrip Xpress 2 Glucose Hospital Meter
System (K152986) | Proposed: StatStrip
Xpress 2 Glucose
Hospital Meter System |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Intended Use | The StatStrip Xpress 2 Glucose Hospital Meter System is
intended for point-of-care, in vitro diagnostic, multiple-patient
use for the quantitative determination of glucose in capillary
finger stick, venous whole blood, arterial whole blood, neonate
arterial whole blood and neonate heel stick specimens.
The StatStrip Xpress 2 Glucose Hospital Meter System is also
intended for use in the quantitative determination of glucose in
venous whole blood, arterial whole blood, neonatal heel stick
and neonatal arterial samples throughout all hospital and all
professional healthcare settings.
The system should only be used with single-use, auto-disabling
lancing devices when performing a capillary finger stick or
neonate heel stick.
It is not intended for use with neonate cord blood specimens.
It is not intended for the screening or diagnosis of diabetes
mellitus but is indicated for use in determining dysglycemia. | Same as Predicate |
| Measuring Range | 10-600 mg/dL | Same as Predicate |
| Hematocrit Range | 20-70 % | Same as Predicate |
| Operating Principle | Electrochemical biosensor | Same as Predicate |
| Operating
Temperature Range | 59-104°F (15-40°C) | 41-104°F (5-40°C) |
| Sample type | Capillary whole blood (finger stick), venous whole blood, arterial
whole blood, neonate heel stick, and neonate arterial whole
blood specimens.
Venous whole blood, arterial whole blood, neonatal heel stick,
and neonatal arterial whole blood samples throughout all
hospital and all professional healthcare settings. | Same as Predicate |
| Sample size | 1.2 uL | Same as Predicate |
| Sample application | Test strip capillary draw | Same as Predicate |
| Handheld meter? | YES | Same as Predicate |
| Meter Calibration | Automatic, no Calibration Code | Same as Predicate |
| Data storage | 400 test results | Same as Predicate |
| Test Time | 6 sec | Same as Predicate |
| Weight | 2.77 oz. | Same as Predicate |
| Bar code scanner | None | Same as Predicate |
| Power source | Two AAA Batteries | Same as Predicate |
| Controls: | Liquid, 3 levels | Same as Predicate |
| Linearity Solutions | Liquid, 5 levels | Same as Predicate |
| Test Strips -
Active reagent: | Glucose Oxidase | Same as Predicate |
| Screen Type | Non segmented Color Display | Same as Predicate |
| Location of Strip Port | Bottom of Meter | Same as Predicate |