(261 days)
Not Found
No
The summary describes a spectrophotometric instrument and cuvettes for measuring hemoglobin. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies.
No.
The device is intended for in vitro quantitative measurement of total hemoglobin, which is a diagnostic function, not therapeutic.
Yes
The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin, which is a diagnostic measurement used to assess conditions like anemia or polycythemia.
No
The device description explicitly states the system consists of an analyzer (a spectrophotometric instrument) and cuvettes, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in blood. "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Measurement of Analytes: The device measures total hemoglobin, which is a specific analyte in a biological sample (blood).
- Use with Biological Samples: The device is designed to be used with human blood (capillary and venous whole blood).
- Point-of-Care Setting: While used at the point of care, the testing itself is performed on a sample taken from the patient, not directly on the patient's body.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.
Product codes (comma separated list FDA assigned to the subject device)
GKR
Device Description
The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.
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
point-of-care settings.
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)
Analytical Performance
- Precision/Reproducibility:
- 20-Day Precision: Performed in accordance with CLSI EP5-A2. Two precision studies were done at clinical sites. This study used three levels of external control material. 240 samples for each level, mean Hgb values of 7.99 g/dL, 12.58 g/dL, and 15.82 g/dL. Total CVs were 1.38%, 1.09%, and 1.41% respectively. Data met criteria of 0.95; Slope within 1.0 +/- 0.1.
Analytical Specificity: All potential interferants showed
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 06, 2018
EKF-diagnostic GmbH Mick Fenton Head of Global QA/RA Ebendorfer Chaussee 3 39179 Barleben Germany
Re: K172173
Trade/Device Name: DiaSpect Tm system Regulation Number: 21 CFR 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: Class II Product Code: GKR Dated: February 20, 2018 Received: March 05, 2018
Dear Mick Fenton:
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 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. 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 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
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172173
Device Name DiaSpect Tm system
The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.
| 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) |
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Section 5 510(k) Summary
510k Number
Introduction
In accordance with the requirements of 21CFR807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
I. Submitter
EKF-diagnostic GmbH Ebendorfer Chaussee 3 39179 Barleben Germany
Tel.: +49 39203 511 0 Fax: +49 39203 511 171
Contact Person: Mick Fenton Phone: +44 0290705274 Email: mickfenton@ekfdiagnostics.com
Secondary Contact: Karen Golomb Phone: +1 (830) 249-072 Fax: +1 (830) 249-0851 Email: karengolomb@ekfdiagnostics.com
Date prepared: 10th July 2017
II. Device Name
| Proprietary names: | DiaSpect Tm system |
|---|---|
| Common names: | As above |
| Classification: | 21 CFR 864.5620 – Automated hemoglobin system |
| Class II | |
| Hematology |
Product Code: GKR
III. Predicate Device
The DiaSpect Tm system is substantially equivalent to the currently marketed HemoPoint® H2 Measurement System (K081719).
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IV. Device Description
The DiaSpect Tm system consists of an analyzer and cuvettes. The DiaSpect Tm analyzer is a spectrophotometric instrument for the total hemoglobin concentration in unaltered human blood. The DiaSpect Tm Cuvette is injection-molded of poly methyl methacrylate (PMMA) and contains a cavity of 10 uL volume. The cavity is empty.
V. Indications for Use
The DiaSpect Tm system is intended for the in vitro quantitative measurement of total hemoglobin in non-anticoagulated capillary whole blood and venous whole blood drawn in K2EDTA or lithium heparin tubes. The DiaSpect Tm system consists of the DiaSpect Tm analyzer and specifically designed disposable cuvettes, the DiaSpect Tm Cuvettes. The device is intended for use in point-of-care settings. The DiaSpect Tm analyzer is only to be used with DiaSpect Tm Cuvettes.
Rx only.
VI. Comparison with Predicate
-
- Predicate device name(s): HemoPoint® H2 Measurement System
-
- Predicate 510(k) number(s): K081719
Similarities compared to the chosen (FDA cleared; marketed) predicate device (K081719)
| Performance | Predicate Device
HemoPoint H2 Measurement
System
(K081719) | Candidate Device
DiaSpect Tm system
(K172173) |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Determine hemoglobin content of
whole blood | Same |
| Analyte | Hemoglobin | Same |
| Sample preparation
(pre-treatment) | None | Same |
| Automation | Fully automated assay | Same |
| Calibration
procedure | Factory calibrated | Same |
| Built in Quality
Control | Auto self-check between
measurements | Same |
| Differences compared to the chosen (FDA cleared; marketed) predicate device (K081719) | | |
| Performance | Predicate Device
HemoPoint H2 Measurement
System
(K081719) | Candidate Device
DiaSpect Tm system
(K172173) |
| Intended Use | The HemoPoint H2 system is
intended for the quantitative
determination of hemoglobin
(Hgb) in whole blood of adults,
infants, and children in a
professional point-of-care
setting. It consists of a dedicated
photometer and individual,
single-use microcuvettes filled
with reagents. | The DiaSpect Tm system is
intended for the in vitro
quantitative measurement of total
hemoglobin in non-
anticoagulated capillary whole
blood and venous whole blood
drawn in K2EDTA or lithium
heparin tubes. The DiaSpect Tm
system consists of the DiaSpect
Tm analyzer and specifically
designed disposable cuvettes, the
DiaSpect Tm Cuvettes. The
device is intended for use in
point-of-care settings. The
DiaSpect Tm analyzer is only to
be used with DiaSpect Tm
Cuvettes. RX only |
| Method of detection
(Test methodology) | Azide methemoglobin | Optical absorbance |
| Sample type | Capillary, arterial or venous | Capillary or venous |
| Sample volume | 8 µL | 2 years to 21 years | 11.0 - 15.5 g/dL |
| Infant | 1 month to 2 years | 9.4 - 16.5 g/dL |
VII. Conclusion
The DiaSpect Tm system data presented and provided is complete and supports the basis for substantial equivalence to the predicate device.