(189 days)
Pharmacia CAP System IgE FEIA, Phadexact Serum Total IgE Controls, Low, Medium, High
No
The description focuses on automated sample handling, reagent processing, and standard curve-based result calculation, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is an in vitro diagnostic assay used for quantitative measurement of total IgE, aiding in the diagnosis of IgE mediated allergic disorders. It does not provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the UniCAP Total IgE Flurorimmunoassay "is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders."
No
The device description explicitly states that the UniCAP system includes the UniCAP 100 instrument, which is a hardware component designed to handle sample and reagent processing. While it includes software, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "UniCAP Total IgE Flurorimmunoassay is an in vitro assay..." and "It is intended for in vitro diagnostic use...". This is the most direct indicator.
- Nature of the Test: The assay measures circulating total IgE in human serum or plasma. This is a biological sample analyzed outside of the body, which is characteristic of in vitro diagnostics.
- Purpose: The assay is used "as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings". This clearly indicates a diagnostic purpose.
- Care Setting: The intended users are "clinical laboratories, as well as, physician office laboratories," which are typical settings for performing in vitro diagnostic tests.
- Control Material: The mention of "Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the performance of total IgE measurements" further supports its use in a diagnostic laboratory setting.
N/A
Intended Use / Indications for Use
- UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative 1. measurement of circulating total IgE in human serum or plasma. UniCAP Total IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as, physician office laboratories.
- Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the 2. performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.
Product codes
82DGC
Device Description
UniCAP is a fully integrated and automated system for the determination of total IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the measurement of total IgE, and Pharmacia Total IgE Control LMH.
The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests; samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.
UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum or plasma
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratories, as well as, physician office laboratories.
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
Comparison studies were performed to establish the substantial equivalence of results using UniCAP 100 and UniCAP Total IgE Assay compared to the corresponding instrumentation and reagents in Pharmacia CAP System.
The comparison study comprised 150 serum samples with concentrations spread over the complete measuring range of the assay. Linear regression analysis gives the equation y = 24.. 5 + 1.05 x, where y represents UniCAP and x represents Pharmacia CAP System. The correlation coefficient is 0.99.
Key Metrics
Correlation coefficient: 0.99 (between UniCAP and Pharmacia CAP System)
Predicate Device(s)
Pharmacia CAP System IgE FEIA, Phadexact Serum Total IgE Controls, Low, Medium, High
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).
0
APR 23 1997
ille
UniCAP Total IgE 510(k) Submission Section 11. Summary of Safety and Effectiveness
SUMMARY OF SAFETY AND EFFECTIVENESS 11.
This summary of safety and effectiveness information is being submitted in accordance with This summary of barber and onlean Devices Act of 1990 (SMDA 1990).
| Date of Summary Preparation: | October 10, 1996 | ||
|---|---|---|---|
| Distributor: | Pharmacia & Upjohn | ||
| Manufacturer: | Pharmacia AB | ||
| S-751 82 Uppsala, Sweden | |||
| Company Contact Person: | Shelley A. Beadle | ||
| Pharmacia & Upjohn | |||
| Director, Regulatory Affairs | |||
| 9200-298-109 | |||
| 7000 Portage Road | |||
| Kalamazoo, MI 49001-0199 | |||
| Device Names: | UniCAP Total IgE Fluoroimmunoassay | ||
| Pharmacia Total IgE Control LMH | |||
| Common Name: | In vitro quantitative assay for the measurement of | ||
| circulating total IgE. | |||
| Classification: | |||
| Product Name | Product Code | Class | CFR |
| UniCAP Total IgE Fluoroimmunoassay | 82DGC | II | 866.5510 |
| Pharmacia Total IgE Control LMH | 82DGC | II | 866.5510 |
Substantial Equivalence to:
Assay:
Pharmacia CAP System IgE FEIA
Control Sera:
Phadexact Serum Total IgE Controls, Low, Medium, High
utsec11.doc 10/14/96
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UniCAP Total IgE 510(k) Submission Section 11. Summary of Safety and Effectiveness
Intended Use Statements:
- UniCAP Total IgE Flurorimmunoassay is an in vitro assay for the quantitative 1. measurement of circulating total IgE in human serum or plasma. UniCAP Total IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as, physician office laboratories.
- Pharmacia Total IgE Control LMH is intended for laboratory use in monitoring the 2. performance of total IgE measurements as determined by Phadebas IgE PRIST /Phadezym IgE PRIST, Pharmacia IgE RIA, Pharmacia IgE RIACT, Pharmacia CAP System IgE RIA/FEIA and UniCAP Total IgE.
General Description:
UniCAP is a fully integrated and automated system for the determination of total IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP RM External Software; UniCAP reagents, in this submission reagents for the measurement of total IgE, and Pharmacia Total IgE Control LMH.
The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests; samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.
UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Total IgE Conjugate or Anti- IgE ImmunoCAP is introduced.
utsec11.doc 10/14/96
02-00072
2
UniCAP Total IgE 510(k) Submission Section 11. Summary of Safety and Effectiveness
Device Comparison:
UniCAP Total IgE Fluoroimmunoassay reagents when used with the UniCAP 100 Instrument are substantially equivalent to another commercially available assay and instrumentation system for the measurement of total IgE, namely Pharmacia CAP System IgE FEIA used with Pharmacia CAP System instrumentation.
Comparison Data:
Comparison studies were performed to establish the substantial equivalence of results using UniCAP 100 and UniCAP Total IgE Assay compared to the corresponding instrumentation and reagents in Pharmacia CAP System.
The comparison study comprised 150 serum samples with concentrations spread over the complete measuring range of the assay. Linear regression analysis gives the equation y = 24.. 5 + 1.05 x, where y represents UniCAP and x represents Pharmacia CAP System. The correlation coefficient is 0.99.
Therefore, Pharmacia & Upjohn concludes that the two systems show excellent correlation, and are substantially equivalent.
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