(140 days)
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No
The summary describes a software program for processing in vitro diagnostic assays and mentions a method comparison study, but there is no mention of AI, ML, or related concepts.
No
The device is described as a software program for processing in vitro diagnostic assays and is intended for "in vitro diagnostic use only," which means it's used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software system is "intended for in vitro diagnostic use only."
Yes
The device is explicitly described as a "software program" and its intended use is for processing data from in vitro diagnostic assays. There is no mention of any associated hardware components being part of the device itself.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states that the software system is for "processing DPC's in vitro diagnostic assays" and is "intended for in vitro diagnostic use only". This is a clear declaration of its IVD nature.
- Device Description: While it's a software program, its purpose is directly tied to processing IVD tests.
The other sections, while providing details about the software's function and performance, do not contradict or negate the initial statement of its intended use as an IVD.
N/A
Intended Use / Indications for Use
DPC's WinMAX software system is a comprehensive software program for processing DPC's in vitro diagnostic assays, the AlaSTAT and AlaTOP immunodiagnostic allergy test kits, in the microtiter plate format . It is intended for in vitro diagnostic use only
Product codes
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Device Description
Software program
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Method Comparison: To demonstrate the equivalence of the performance of the WinMAX and MAXsoftware systems, a comparison was made of 262 serum samples tested for a variety of allergens using both software systems. Of the 262 samples tested, 163 samples gave quantitative results that were within the reportable ranges of both software systems. Linear regression of these 163 sample results yielded: WinMAX = 0.76 * MAXsoftware + 0.91 KU/L, with a correlation coefficient of 0.960.
Key Metrics
Correlation coefficient of 0.960.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.2170 Micro chemistry analyzer for clinical use.
(a)
Identification. A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Diagnostic Products Corporation WinMAX Software System April 10, 1997
MAY - 9 1997
510 (k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
| Name:
Address: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Facsimile Number: | (213) 776-0180
(213) 776-0204 |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation: | March 20, 1997 |
| Device Name: | WinMAX software system |
| Trade: | Software program for processing AlaSTAT and AlaTOP
immunodiagnostic allergy test kits. |
| Catalog Number: | WinMAX |
| Classification: | Class I device, (21 CFR 862.2300) |
| Level of Concern: | We believe the level of concern of this device to be minor,
based on definitions established in the "Review Guidance
for Computer Controlled Medical Devices Undergoing
510(k) Review" |
| Hazards associated
with the device: | We believe the hazards associated with malfunction of the
device to be minimal. At the worst, software malfunction
could lead to misdiagnosis of patient allergy. |
| Manufacturer: | EURO/DPC Ltd., a wholly-owned subsidiary of DPC
(Manufacturing under a Quality System-ISO
9002/EN29002/BS 5750) |
| Sole U.S. Importer: | Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, CA 90045-5597 |
| Establishment Registration Number: | DPC's Registration Number is 2017183 |
| Description of Device: | Software program |
| Intended Use of the Device: | DPC's WinMAX software system is a comprehensive
software program for processing DPC's in vitro
diagnostic assays, the AlaSTAT and AlaTOP
immunodiagnostic allergy test kits, in the microtiter plate
format . It is intended for in vitro diagnostic use only |
1
Diagnostic Products Corporation WinMAX Software System April 10, 1997
Method Comparison:
To demonstrate the equivalence of the performance of the WinMAX and MAXsoftware systems, a comparison was made of 262 serum samples tested for a variety of allergens using both software systems. Of the 262 samples tested, 163 samples gave quantitative results that were within the reportable ranges of both software systems. Linear regression of these 163 sample results yielded: WinMAX = 0.76 * MAXsoftware + 0.91 KU/L, with a correlation coefficient of 0.960.
Conclusion:
The conclusions drawn from the noncligical tests demonstrate that the device is safe and effective.
Gdwara Lereer
4/10/97
Date
Edward M. Levine, Ph.D. Director of Clinical Affairs Date