(108 days)
K884276A, K902484, K884597A
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No
The summary describes a reagent and calibrator used with an existing immunochemistry system for quantitative determination of light chains using rate nephelometry. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on standard analytical validation metrics like method comparison, stability, and imprecision.
No
The device is intended for the quantitative determination of specific light chains, which is a diagnostic function, not a therapeutic one.
Yes
The device is described as "intended for the quantitative determination of kappae light chains (free and bound) by rate nephelometry" and "quantitative determination of lambda light chains (free and bound) by rate nephelometry" in human serum and urine samples. These are measurements used for diagnostic purposes.
No
The device description explicitly states it is a "Reagent," which is a chemical substance used in a laboratory test, indicating it is a physical component and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states the reagents are "intended for the quantitative determination of kappa light chains (free and bound)" and "intended for the quantitative determination of lambda light chains (free and bound)". This indicates the device is used to analyze a sample taken from the human body to provide information about a physiological state.
- Device Description: It further clarifies that the reagents are for use in "quantitative determination of kappa and lambda light chain concentrations respectively in human serum and urine samples". Serum and urine are biological specimens.
- Performance Studies: The document describes method comparison, stability, and imprecision studies, which are typical performance evaluations for IVD devices.
- Predicate Device(s): The mention of predicate devices with K numbers (K884276A, K902484, K884597A) strongly suggests that this device is being submitted for regulatory review as an IVD, as predicate devices are used to demonstrate substantial equivalence for new IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IMMAGE™ Immunochemistry System Kappa (KAP) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of kappe light chains (free and bound) by rate nephelometry.
The IMMAGE™ Immunochemistry System Lambda (LAM) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is Intended for the quantitative determination of lambda light chains (free and bound) by rate nephelometry.
Product codes
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Device Description
The IMMAGE Immunochemistry System KAP and LAM Reagents in conjunction with Beckman Calibrator 1, are intended for use in the quantitative determination of kappa and lambda light chain concentrations respectively in human serum and urine samples on Beckman's IMMAGE Immunochemistry System.
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
The data in the Premarket Notification on safety and effectiveness supports a finding of Equivalence to other test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision studies that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents.
Method Comparison Study Results IMMAGE Kappa (KAP) and Lambda (LAM) Reagents:
- IMMAGE KAP Reagent (serum): Slope 1.037, Intercept -9.16, r 0.987, n 220. Predicate Method: Beckman KAP Reagent.
- IMMAGE KAP Reagent (urine): Slope 0.970, Intercept 1.36, r 0.980, n 103. Predicate Method: Beckman KAP Reagent.
- IMMAGE LAM Reagent (serum): Slope 1.020, Intercept -23.5, r 0.991, n 236. Predicate Method: Beckman LAM Reagent.
- IMMAGE LAM Reagent (urine): Slope 1.009, Intercept -0.08, r 0.954, n 40. Predicate Method: Beckman LAM Reagent.
Stability Study Results:
- IMMAGE KAP & LAM: 24 month shelf-life, 14 day open container stability, 14 day calibration stability.
Estimated Within-Run Imprecision:
- Kappa Light Chain (KAP) Serum:
- Level 1: Mean (ug/mL) 540, S.D.(ug/mL) 15.6, %C.V. 2.9, N 80.
- Level 2: Mean (ug/mL) 1113, S.D.(ug/mL) 24.1, %C.V. 2.2, N 80.
- Level 3: Mean (ug/mL) 2377, S.D.(ug/mL) 61.2, %C.V. 2.6, N 80.
- Kappa Light Chain (KAP) Urine:
- Level 1: Mean (ug/mL) 2.33, S.D.(ug/mL) 0.059, %C.V. 2.5, N 30.
- Level 2: Mean (ug/mL) 9.34, S.D.(ug/mL) 0.236, %C.V. 2.5, N 30.
- Level 3: Mean (ug/mL) 19.2, S.D.(ug/mL) 0.25, %C.V. 1.3, N 30.
- Lambda Light Chain (LAM) Serum:
- Level 1: Mean (ug/mL) 247, S.D.(ug/mL) 5.1, %C.V. 2.1, N 80.
- Level 2: Mean (ug/mL) 718, S.D.(ug/mL) 14.0, %C.V. 1.9, N 80.
- Level 3: Mean (ug/mL) 1233, S.D.(ug/mL) 37.2, %C.V. 3.0, N 80.
- Lambda Light Chain (LAM) Urine:
- Level 1: Mean (ug/mL) 8.69, S.D.(ug/mL) 0.204, %C.V. 2.4, N 30.
- Level 2: Mean (ug/mL) 17.1, S.D.(ug/mL) 0.20, %C.V. 1.2, N 30.
- Level 3: Mean (ug/mL) 30.0, S.D.(ug/mL) 0.89, %C.V. 3.0, N 30.
Key Metrics
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Predicate Device(s)
K884276A, K902484, K884597A
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).
0
BECKMAN
Summary of Safety & Effectiveness IMMAGE™ Immunochemistry System Kappa (KAP) and Lambda (LAM) Light Chain Reagents
Submitted By: 1.0
Annette Hellie Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
FEB 1 0 1997
2.0 Date Submitted:
24 October 1996
3.0 Device Name(s):
3.1 Proprietary Names
IMMAGE™ Immunochemistry System Kappa Light Chain (KAP) Reagent IMMAGE™ Immunochemistry System Lambda Light Chain (LAM) Reagent
Classification Name 3.2
Immunoglobulin (light chain specific) immunological test system (21 CFR § 866.5550)
4.0 Predicate Device(s):
| IMMAGE System
Reagent | Predicate | Manufacturer | Docket
Number |
|---------------------------------------|---------------------------------------------|------------------------------|---------------------|
| IMMAGE System
Kappa (KAP) Reagent | Beckman Kappa Light
Chain (KAP) Reagent | Beckman Instruments,
Inc. | K884276A
K902484 |
| IMMAGE System
Lambda (LAM) Reagent | Beckman Lambda Light
Chain (LAM) Reagent | Beckman Instruments,
Inc. | K884597A
K902484 |
Beckman Instruments, Inc.
ਛੱਡ
1
Description: 5.0
The IMMAGE Immunochemistry System KAP and LAM Reagents in conjunction with Beckman Callbrator 1, are intended for use in the quantitative determination of kappa and lambda light chain concentrations respectively in human serum and urine samples on Beckman's IMMAGE Immunochemistry System.
6.0 Intended Use:
The IMMAGE Immunochemistry System Kappa (KAP) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is intended for the quantitative determination of kappe light chains (free and bound) by rate nephelometry.
The IMMAGE Immunochemistry System Lambda (LAM) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 1, is Intended for the quantitative determination of lambda light chains (free and bound) by rate nephelometry.
Comparison 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 | ||
| KAP and LAM | ||
| Reagents | Initial Analytic Range | Same as |
| Beckman Kappa and Lambda | ||
| Light Chain reagents | ||
| Nephelometric methodology | ||
| Antibody source (goat) | ||
| DIFFERENCES | ||
| IMMAGE System | ||
| KAP and LAM | ||
| Reagents | Antigen excess testing solution | IMMAGE KAP & LAM have |
| antigen excess testing solution | ||
| included in the reagent | ||
| cartridge, while the Beckman | ||
| Kappa and Lambda require | ||
| off-line preparation of the | ||
| solution. | ||
| Antibody concentration | IMMAGE KAP and LAM have | |
| a higher antibody | ||
| concentration than the | ||
| Beckman Kappa and Lambda | ||
| reagents |
2
Summary of Performance Data: 8.0
The data in the Premarket Notification on safety and effectiveness supports a finding of The Gata in the Fromance Houster test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, and imprecision Equivalents that relate results obtained from the Beckman Reagents to the IMMAGE System Reagents.
| Analyte | Sample Type | Slope | Intercept | r | n | Predicate Method |
|---|---|---|---|---|---|---|
| IMMAGE | ||||||
| KAP | ||||||
| Reagent | serum | 1.037 | -9.16 | 0.987 | 220 | Beckman KAP |
| Reagent | ||||||
| urine | 0.970 | 1.36 | 0.980 | 103 | ||
| IMMAGE | ||||||
| LAM | ||||||
| Reagent | serum | 1.020 | -23.5 | 0.991 | 236 | Beckman LAM |
| Reagent | ||||||
| urine | 1.009 | -0.08 | 0.954 | 40 |
Method Comparison Study Results IMMAGE Kaona (KAP) and Lambda (LAM) Reagents
Stability Study Results
| Reagent | Product Claims |
|---|---|
| IMMAGE KAP & LAM | 24 month shelf-life |
| 14 day open container stability | |
| 14 day calibration stability |
2
3
Estimated Within-Run Imprecision
| Sample | Mean (ug/mL) | S.D.(ug/mL) | %C.V. | N |
|---|---|---|---|---|
| Kappa Light Chain (KAP) Serum | ||||
| Level 1 | 540 | 15.6 | 2.9 | 80 |
| Level 2 | 1113 | 24.1 | 2.2 | 80 |
| Level 3 | 2377 | 61.2 | 2.6 | 80 |
| Sample | Mean (ug/mL) | S.D. (ug/mL) | %C.V. | N |
|---|---|---|---|---|
| Kappa Light Chain (KAP) Urine | ||||
| Level 1 | 2.33 | 0.059 | 2.5 | 30 |
| Level 2 | 9.34 | 0.236 | 2.5 | 30 |
| Level 3 | 19.2 | 0.25 | 1.3 | 30 |
| Sample | Mean (ug/mL) | S.D. (ug/mL) | %C.V. | N |
|---|---|---|---|---|
| Lambda Light Chain (LAM) Serum | ||||
| Level 1 | 247 | 5.1 | 2.1 | 80 |
| Level 2 | 718 | 14.0 | 1.9 | 80 |
| Level 3 | 1233 | 37.2 | 3.0 | 80 |
| Sample | Mean (ug/mL) | S.D. (ug/mL) | %C.V. | N |
|---|---|---|---|---|
| Lambda Light Chain (LAM) Urine | ||||
| Level 1 | 8.69 | 0.204 | 2.4 | 30 |
| Level 2 | 17.1 | 0.20 | 1.2 | 30 |
| Level 3 | 30.0 | 0.89 | 3.0 | 30 |
This summary of safety and effectiveness is being submitted in according mith the This Summary of Safety and Chockvenoce 16 being our the implementing regulation 21 CFR 807.92.