(24 days)
The provided text "Not Found" does not contain any information about Predicate Devices or their K/DEN numbers. Therefore, I cannot extract the requested information.
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The "Intended Use / Indications for Use" states that the device's labeling "HAS NOT CHANGED," implying it inherits the therapeutic status of its predicate device if any. However, the predicate device, K121366 HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System, is a monitoring system for hemoglobin, which is a diagnostic or measurement device, not a therapeutic one. Therapeutic devices are designed to treat or cure a disease or condition, not just monitor it.
Yes
The device is compared to a predicate device (K121366; HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System) which is a monitoring system for glycosylated hemoglobin. Monitoring systems for biomarkers like HbA1c are typically used to diagnose or manage medical conditions, thus classifying this device, which has an unchanged indication/intended use, as diagnostic.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The predicate device listed (HemoCue® HbA1c 501) is a hardware system, which further suggests the modified device might also involve hardware.
Based on the provided information, it is highly likely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Predicate Device: The predicate device listed is the "HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System" (K121366). HemoCue devices are well-known for performing in vitro diagnostic tests, specifically for measuring hemoglobin and related parameters in blood samples.
- Intended Use: While the specific intended use is not detailed, the statement "the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED" implies that the device performs the same function as the predicate device. Since the predicate is an IVD for measuring glycosylated hemoglobin, it's reasonable to assume the modified device also performs this type of in vitro test.
The lack of information in other sections (Device Description, Image Processing, AI/ML, etc.) doesn't contradict the IVD classification, as not all IVDs involve these aspects. The key indicator here is the predicate device.
N/A
Not Found
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
SPECIAL 510(k): Device Modification OIR Review Memorandum
THE FILE RE: DOCUMENT NUMBER_K141750 To:
This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable:
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- The name and 510(k) number of Infopia Co., Ltd.'s previously cleared device HemoCue® HbA1c 501 Glycosylated Hemoglobin Monitoring System, cleared under K121366.
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- 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, system and software operations manuals.
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- 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 was for:
- appearance change of the test cartridge, daily check cartridge and monthly check cartridge to ● improve usability:
- . color change of the bead window on the daily check cartridge to allow light intensity check in daily check cartridge test;
- addition of shelf life for the daily check cartridge; ●
- addition of a check function at the initialization stage; ●
- . addition of automatic mode change after an error message.
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- Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labelinq, intended use, and physical characteristics.
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- 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
- c) A declaration of conformity with design controls. The declaration of conformity should include:
- A statement signed by the individual responsible, that, as required by the risk analysis, all i) verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
- A statement signed by the individual responsible, that the manufacturing facility is in ii) conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.
6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).
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 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.