(77 days)
I'm sorry, I cannot fulfill that request. Please provide the text from which I should extract the K/DEN numbers. The current input is "Not Found".
I'm sorry, but I cannot fulfill your request. The provided input text "Not Found" does not contain any information about K/DEN numbers or reference devices. Therefore, I cannot identify or list them.
No
The description focuses on automation of standard laboratory processes and data management, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is a laboratory analyzer used to diagnose coagulation abnormalities or monitor anticoagulant therapy. It performs tests and analyzes samples, but it does not directly treat or cure any conditions; therefore, it is not a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the instrument is "designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy."
No
The device description explicitly states it is a "fully automated laboratory analyzer" and describes physical components like sample handling, reagent delivery, and a central processing unit controlling instrument functions. This indicates it is a hardware device with integrated software, not a software-only medical device.
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 instrument is "designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy." This clearly indicates that the device is used to examine specimens taken from the human body (in vitro) to provide information for diagnostic purposes.
- Device Description: The description further clarifies that it's a "laboratory analyzer" that performs "clot-based tests and photometric assays." These are common types of tests performed on biological samples in a laboratory setting.
- Use of Reagents: The mention of using "Diagnostica Stago (France) reagents" and being "open to adaptation of other reagents" is typical of IVD devices, which require specific reagents to perform the intended tests on patient samples.
The definition of an IVD device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description.
N/A
Not Found
§ 864.5400 Coagulation instrument.
(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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AMERICAN BIOPRODUCTS COMPANY Pre-Market 510(k) Notification STA Compact® Automated Multi-Parametric Analyzer
11 1 0 1996
IX. SAFETY AND EFFECTIVENESS SUMMARY
The STA Compact instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once samples and test reagents are loaded onto the instrument, sample handling. reagent delivery, analysis and reporting of test results are performed automatically, making the STA Compact instrument a true walkaway system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization.
The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently available from third-party manufacturers. Barcoding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents.
The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.
Sample-to-sample carryover has been demonstrated to be very low, being of the order of 5/100th of 1% (i.e., 0.05%).
The STA Compact instrument is substantially equivalent to the commercially available full-size STA® analyzer that received FDA 510(k) clearance under K942117.