(163 days)
No K/DEN numbers were provided in the text.
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No
The description focuses on a reagent and its performance in a standard immunochemistry system using rate nephelometry, with no mention of AI or ML.
No
This device is an in vitro diagnostic (IVD) reagent used for the quantitative determination of prealbumin in human serum, which aids in diagnosis rather than directly treating or preventing a disease.
Yes
The device is intended for the quantitative determination of human prealbumin concentrations in human serum samples, which is a measurement used to aid in disease diagnosis and monitoring.
No
The device description clearly states it is a reagent kit containing a cartridge of reagent, evaporation caps, and a barcode card, which are physical components, not software.
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 reagent is "intended for use in the quantitative determination of human prealbumin concentrations in human serum samples". This indicates that it is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description confirms it's a "reagent" used for "quantitative determination of human prealbumin concentrations in human serum samples". Reagents used for testing biological samples are a core component of IVDs.
- Performance Studies: The performance studies describe method comparison, stability, and imprecision experiments, which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (Beckman Immunochemistry Systems PAB Prealbumin Reagent) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
All these elements strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IMMAGE™ Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.
Product codes
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Device Description
The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent, in coniunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison Study Results IMMAGE PAB Reagent vs. Beckman Prealbumin Reagent (PAB) on ARRAY:
Analyte: IMMAGE PAB
Sample Type: Serum
Slope: 0.992
Intercept: -0.307
r: 0.985
n: 124
Predicate: Beckman Prealbumin Reagent (PAB) on the ARRAY® Systems
Stability Study Results:
Reagent: IMMAGE PAB Reagent System
Product Claim: 24 month shelf-life, 14 day open container stability, 14 day calibration stability
Precision Study Results IMMAGE PAB Reagent:
Material Serum: Level 1, Level 2, Level 3
Within Run Precision:
Level 1: Mean 16.4 mg/dL, SD 0.29, %CV 1.8, N 80
Level 2: Mean 25.5 mg/dL, SD 0.51, %CV 2.0, N 80
Level 3: Mean 44.7 mg/dL, SD 0.72, %CV 1.6, N 80
Total Precision:
Level 1: Mean 16.4 mg/dL, SD 0.33, %CV 2.0, N 80
Level 2: Mean 25.5 mg/dL, SD 0.59, %CV 2.3, N 80
Level 3: Mean 44.7 mg/dL, SD 0.81, %CV 1.8, N 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Beckman Immunochemistry Systems PAB Prealbumin Reagent
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5060 Prealbumin immunological test system.
(a)
Identification. A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.(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 § 866.9.
0
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Preaibumin (PAB) Reagent Summary of Safety & Effectiveness
K964781
MAY 9, 1997
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent
Submitted By: 1.0
Frank Marte, R.A.C. Sr. Regulatory Affairs Specialist Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea. California 92822-8000 Telephone: (714) 961-4406 FAX: (714) 961-4457
2.0 Date Submitted:
22 November 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent
3.2 Classification Names
Prealbumin immunological test system (21 CFR 866.5060)
4.0 Predicate Device(s):
Beckman Immunochemistry Systems PAB Prealbumin Reagent
5.0 Description:
The IMMAGE Immunochemistry System Prealbumin (PAB) Reagent, in coniunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples. The reagent kit contains one cartridge of reagent, evaporation caps and a lot specific bar code card. Calibrators and control materials are purchased separately.
1
6.0 Intended Use:
The IMMAGE Immunochemistry System Prealbumin (PAB) reagent, in conjunction with Beckman Calibrator 3, is intended for use in the quantitative determination of human prealbumin concentrations in human serum samples by rate nephelometry. This assay is designed for use with the Beckman IMMAGE Immunochemistry System.
Companson to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| IMMAGE | ||
| System (PAB) | ||
| Reagent | Assay method - rate nephelometry ✓ | |
| Serum: | ||
| Analytic Range: 7.0 - 50 mg/dL ✓ | ||
| Extended Range: 1.17 - 1800 mg/dL | ||
| Sample and reagent ratios ✓ | ||
| Antibody source (goat) ✓ | ||
| Shelf life of 24 months ✓ | ||
| (stored at 2 -8°C) | Same as Beckman's | |
| Immunochemistry System | ||
| Prealbumin PAB Reagent | ||
| as run on the ARRAY® | ||
| System | ||
| DIFFERENCES | ||
| IMMAGE | ||
| System (PAB) | ||
| Reagent | Reaction Temperature | IMMAGE System PAB |
| assays run at 37°C and | ||
| the predicate runs at | ||
| 26.7°C | ||
| Buffer/Reagent Volume | IMMAGE System PAB | |
| Reagent uses one half | ||
| the volume utilized by the | ||
| Array System for the PAB | ||
| assay |
2
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Prealbumin (PAB) Reagent Summary of Safety & Effectiveness
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness The bata in the fromantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision experiments that relate mother obtained from the Beckman Immunochemistry System PAB Prealburnin (on ARRAY) Reagent to the IMMAGE System PAB Reagent.
Method Comparison Study Results IMMAGE PAB Reagent vs. Beckman Prealbumin Reagent (PAB) on ARRAY
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| PAB | Serum | 0.992 | -0.307 | 0.985 | 124 | Beckman |
| Prealbumin | ||||||
| Reagent (PAB) | ||||||
| on the | ||||||
| ARRAY® | ||||||
| Systems |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE PAB Reagent | |
| System | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
3
Beckman Instruments, Inc., Section 510(k) Notification Beckman Instruments, mistry System Prealbumin (PAB) Reagent Summary of Safety & Effectiveness
Precision Study Results IMMAGE PAB Reagent
| Material
Serum | Mean
(mg/dL) | SD ( ) | %CV | N |
|----------------------|-----------------|--------|-----|----|
| Within Run Precision | | | | |
| Level 1 | 16.4 | 0.29 | 1.8 | 80 |
| Level 2 | 25.5 | 0.51 | 2.0 | 80 |
| Level 3 | 44.7 | 0.72 | 1.6 | 80 |
| Total Precision | | | | |
| Level 1 | 16.4 | 0.33 | 2.0 | 80 |
| Level 2 | 25.5 | 0.59 | 2.3 | 80 |
| Level 3 | 44.7 | 0.81 | 1.8 | 80 |
This summary of safety and effectiveness is being submitted in This Sammary - of - Carolyements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92