(47 days)
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No
The summary describes a reagent and system for quantitative determination of haptoglobin using rate nephelometry, a standard laboratory technique. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is described as a reagent for quantitative determination, not as a treatment or therapy.
Yes
The device is described as being used for the "quantitative determination of human haptoglobin concentrations in human serum samples," which is a measurement used to aid in disease diagnosis or monitoring.
No
The device is described as a reagent and calibrator for use with an immunochemistry system, indicating it is a chemical component used in a laboratory instrument, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of human haptoglobin concentrations in human serum samples". This indicates the device is used to analyze a biological sample (human serum) outside of the body (in vitro) to provide diagnostic information (haptoglobin concentration).
- Device Description: The description reiterates the intended use, confirming it's for analyzing human serum samples.
- 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" which is another "Immunochemistry Systems HPT Haptoglobin Reagent" further supports that this device falls under the category of IVDs, as predicate devices are used for comparison in the regulatory process for new IVDs.
The core function of analyzing a biological sample in vitro to provide diagnostic information is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
Product codes
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Device Description
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples.
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, stability, and imprecision experiments were conducted.
Method Comparison Study Results:
Analyte: IMMAGE HPT, Slope: 1.004, Intercept: -6.80, r: 0.996, Predicate: Beckman's HPT Haptoglobin Reagent on the Array Systems.
Stability Study Results:
IMMAGE HPT: 24 month shelf-life, 14 day open container stability, 14 day calibration stability.
Estimated Within-Run Imprecision:
HPT Reagent Level 1: Mean (mg/dL) 60.8, SD (mg/dL) 0.87, %CV 1.4, Number of Results 80.
HPT Reagent Level 2: Mean (mg/dL) 136, SD (mg/dL) 3.4, %CV 2.5, Number of Results 80.
HPT Reagent Level 3: Mean (mg/dL) 322, SD (mg/dL) 9.7, %CV 2.8, Number of Results 80.
Key Metrics
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Predicate Device(s)
Beckman Immunochemistry Systems HPT Haptoglobin Reagent
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5460 Haptoglobin immunological test system.
(a)
Identification. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
OCT 7 1996
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent
1.0 Submitted By:
100 m
Margie George Project Manager. System Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3765 FAX: (714) 961-3759
2.0 Date Submitted:
23 Aug-1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent
3.2 Classification Names
Haptoglobin immunological test system(21 CFR 866.5460)
4.0 Predicate Device(s):
Beckman Immunochemistry Systems HPT Haptoglobin Reagent
5.0 Description:
The IMMAGE Immunochemistry System Haptoglobin (HPT) reagent, in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples.
6.0 Intended Use:
IMMAGE Immunochemistry System Haptoglobin (HPT) The reagent. in conjunction with Beckman Calibrator 1, is intended for use in the quantitative determination of human haptoglobin concentrations in human serum samples by rate nephelometry. This assay is designed for use with Beckman's IMMAGE Immunochemistry System.
1
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent Summary of Safety & Effectiveness
7.0 Comparison to Predicate(s):
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 | ||
| (HPT) Reagent | Assay method - rate nephelometry | Same as Beckman's HPT |
| Haptoglobin Reagent | ||
| Analytic Range 35 - 350 mg/dL | ||
| Extended Range 5.8 - 12,600 mg/dL | Same as Beckman's HPT | |
| Haptoglobin Reagent | ||
| Sample and reagent ratios | Same as Beckman's HPT | |
| Haptoglobin Reagent | ||
| Antibody | Same as Beckmna's HPT | |
| Haptoglobin Reagent | ||
| Shelf life of 24 months (stored at 2- | ||
| 8°C) | Same as Beckman's HPT | |
| Haptoglobin Reagent | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| (HPT) Reagent | Reaction Temperature | IMMAGE System HPT assays |
| run at 37°C and the predicate | ||
| runs at 26.7°C | ||
| Antigen excess solution (AGXS) | IMMAGE System HPT | |
| Reagent AGXS is prediluted | ||
| and present in the reagent | ||
| cartridge while the predicate | ||
| requires off-line preparation of | ||
| the solution |
2
Beckman Instruments, Inc., Section 510(k) Notification IMMAGE™ Immunochemistry System Haptoglobin (HPT) Reagent Summary of Safety & Effectiveness
8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method companson, stability, and imprecision experiments that relate results obtained from the Beckman Haptoglobin Reagent to the IMMAGE HPT Reagent.
Method Comparison Study Results IMMAGE HPT Reagent vs. Beckman Haptoglobin Reagent
| Analyte | Slope | Intercept | r | Predicate |
|---|---|---|---|---|
| IMMAGE | ||||
| HPT | 1.004 | -6.80 | 0.996 | Beckman's HPT |
| Haptoglobin | ||||
| Reagent on the | ||||
| Array® | ||||
| Systems |
Stability Study Results
| Reagent | Product Claim |
|---|---|
| IMMAGE HPT | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
Estimated Within-Run Imprecision
| MATERIAL | MEAN (mg/dL) | SD (mg/dL) | %CV | Number of Results |
|---|---|---|---|---|
| HPT Reagent | ||||
| Level 1 | 60.8 | 0.87 | 1.4 | 80 |
| Level 2 | 136 | 3.4 | 2.5 | 80 |
| Level 3 | 322 | 9.7 | 2.8 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.