(90 days)
P850048
Not Found
No
The description details a standard ELISA assay and automated system for quantitative determination of PSA. There is no mention of AI or ML in the device description, intended use, or performance studies. The results are determined from a calibration curve, a standard method in quantitative assays, not an AI/ML model.
No.
This device is an in vitro diagnostic test for measuring Prostate-Specific Antigen, used for diagnostic purposes rather than for treating or preventing disease.
Yes
Explanation: The device quantitatively determines Prostate-Specific Antigen (PSA) in serum and plasma, which is used for diagnostic purposes (e.g., prostate cancer screening or monitoring).
No
The device is an in vitro diagnostic (IVD) test kit that utilizes chemical reactions and a physical measurement (photometry) to determine PSA levels. It is designed to run on specific automated immunoassay systems, indicating a reliance on hardware beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma." Serum and plasma are biological specimens taken from the human body.
- Device Description: The description details an "Enzyme-linked immunosorbent assay" which is a laboratory test performed on biological samples.
- Test Principle: The test principle involves chemical and immunological reactions with components of the biological sample (PSA).
- Performance Characteristics: The document provides performance characteristics like precision, sensitivity, and assay range, which are typical for IVD devices used to analyze biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Enzyme-linked immunosorbent assay for the quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma.
Product codes
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Device Description
The Enzymun-Test PSA test principle is an ELISA/1-step sandwich assay using streptavidin technology. The assay procedure is designed to run on the Boehringer Mannheim Automated Immunoassay Systems. In the first incubation step (immunological reaction) the PSA in the sample reacts with the biotinylated anti-PSA antibodies, which are in turn bound to the streptavidin-coated tube wall. The PSA is also bound to the peroxidase (POD)-labeled monoclonal antibody (anti-PSA POD-conjugate) to form a sandwich complex. The quantity of antibody-PSA POD complex formed is a measure of the PSA content of the sample. The unbound POD-conjugate is removed along with serum constituents in the separation step. The activity of the POD bound to the tube wall is determined photometrically after the addition of the chromogen and the substrate H2O2 (from sodium perborate). In the indicator reaction, the chromophore formed is a dark green cation whose concentration is directly proportional to the PSA concentration in the sample. The color intensity that develops within a fixed period of time is measured against the substrate/chromogen blank. The test results are determined from a calibration curve derived using the standards provided in the kit.
Mentions image processing
Not Found
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)
Precision:
Enzymun-Test PSA:
NCCLS EP5-T2 protocol
within run:
Pool 1: N=63, x̄=0.28, CV=6.0
Pool 2: N=63, x̄=3.07, CV=3.0
Pool 3: N=63, x̄=39.64, CV=2.6
TMI: N=63, x̄=1.19, CV=3.4
TMII: N=63, x̄=6.43, CV=3.0
Total:
Pool 1: N=63, x̄=0.28, CV=15.2
Pool 2: N=63, x̄=3.07, CV=4.3
Pool 3: N=63, x̄=39.64, CV=4.4
TMI: N=63, x̄=1.19, CV=5.0
TMII: N=63, x̄=6.43, CV=4.0
Hybritech Tandem-R PSA:
within run: (20 replicates from 3 runs)
1: N=60, x̄=2.98, CV=2.7
2: N=60, x̄=6.99, CV=1.6
3: N=60, x̄=36.34, CV=1.1
between run:
1: N=201, x̄=3.05, CV=5.6
2: N=201, x̄=7.14, CV=3.2
3: N=201, x̄=35.71, CV=3.7
inter-laboratory:
1: N=8, x̄=3.06, CV=5.56
2: N=8, x̄=13.27, CV=5.12
3: N=8, x̄=31.48, CV=4.42
4: N=8, x̄=83.59, CV=2.64
Sensitivity:
Enzymun-Test PSA: Lower detection limit: 0.05 ng/ml
Hybritech Tandem-R PSA: Minimum detectable conc.: 0.15 ng/ml
Assay range (LDL to highest standard):
Enzymun-Test PSA: 0.05 ng/ml - 50 ng/ml
Hybritech Tandem-R PSA: 0.15 ng/ml - 100 ng/ml
Interfering Substances (No interference up to):
Enzymun-Test PSA:
hemoglobin: 700 mg/dl
bilirubin: 64.5 mg/dl
lipemia: 1250 mg/dl (Intralipid)
Hybritech Tandem-R PSA:
hemoglobin: 200 mg/dl
bilirubin: 25 mg/dl
lipemia: 2320 mg/dl
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity:
Enzymun-Test PSA: Lower detection limit: 0.05 ng/ml
Hybritech Tandem-R PSA: Minimum detectable conc.: 0.15 ng/ml
Predicate Device(s)
P850048
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
0
K96 5085
票
MAR | 9 |997
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 845-2000 | |
| Contact Person: LeeAnn Chambers | |
| Date Prepared: November 15, 1996 | |
| 2) Device name | Proprietary name: Enzymun-Test® PSA |
| Common name: tumor associated antigen immunological test system | |
| Classification name: Prostate-specific antigen (PSA), immunological test system for the management of prostate cancer | |
| 3) Predicate device | We claim substantial equivalence to the Hybritech Tandem®-R PSA (P850048). |
| 4) Device Description | The Enzymun-Test PSA test principle is an ELISA/1-step sandwich assay using streptavidin technology. The assay procedure is designed to run on the Boehringer Mannheim Automated Immunoassay Systems. |
| In the first incubation step (immunological reaction) the PSA in the sample reacts with the biotinylated anti-PSA antibodies, which are in turn bound to the streptavidin-coated tube wall. The PSA is also bound to the peroxidase (POD)-labeled monoclonal antibody (anti-PSA POD-conjugate) to form a sandwich complex. The quantity of antibody-PSA POD complex formed is a measure of the PSA content of the sample. The unbound POD-conjugate is removed along with serum constituents in the separation step. |
Continued on next page
1
510(k) Summary, Continued
| 4) Device Description, (cont.) The activity of the POD bound to the tube wall is determined photometrically after the addition of the chromogen and the substrate H2O2 (from sodium perborate). In the indicator reaction, the chromophore formed is a dark green cation whose concentration is directly proportional to the PSA concentration in the sample. The color intensity that develops within a fixed period of time is measured against the substrate/chromogen blank.
| The test results are determined from a calibration curve derived using the standards provided in the kit. |
|---|
| 5) Intended use Enzyme-linked immunosorbent assay for the quantitative determination of Prostate-Specific Antigen (PSA) in serum and plasma. |
| 6) Comparison to predicate device The Boehringer Mannheim Enzymun-Test PSA is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Hybritech Tandem-R PSA. |
The following table compares the Enzymun-Test PSA with the predicate device Hybritech Tandem-R PSA.
Similarities: Intended use: for the quantitative measurement of prostate-specific antigen (PSA) to aid in the prognosis and management of patients with prostate cancer. Both assays use mouse monoclonal antibodies to bind and detect PSA Both assays use 50 $μ$ l sample volume. |
Continued on next page
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ਾਰਡ
2
510(k) Summary, Continued
- Comparison Differences: to predicate device, (cont.)
.
| Feature | Enzymun-Test PSA | Hybritech Tandem-R PSA |
|---|---|---|
| Sample type | Human serum and plasma | Human serum |
| Detection | ||
| method | Enzyme linked | |
| immunosorbent assay | Radioimmunoassay | |
| Instrument | ||
| required | ES 300 or other ES system | γ-PHOTON System or gamma |
| counter | ||
| Calibration | Full calibration curve every 2 | |
| weeks with a 1 point | ||
| recalibration with every run | Full calibration curve with | |
| every run |
୍ଲା
Performance Characteristics:
| Feature | Enzymun-Test PSA | Hybritech Tandem-R PSA | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Precision | NCCLS EP5-T2 protocol | within run: (20 replicates from 3 runs) | |||||||||
| within run: | |||||||||||
| Pool 1 | Pool 2 | Pool 3 | TMI | TMII | 1 | 2 | 3 | ||||
| N | 63 | 63 | 63 | 63 | 63 | N | 60 | 60 | 60 | ||
| x̄ | 0.28 | 3.07 | 39.64 | 1.19 | 6.43 | x̄ | 2.98 | 6.99 | 36.34 | ||
| CV | 6.0 | 3.0 | 2.6 | 3.4 | 3.0 | CV | 2.7 | 1.6 | 1.1 | ||
| Total: | between run: | ||||||||||
| Pool 1 | Pool 2 | Pool 3 | TMI | TMII | 1 | 2 | 3 | ||||
| N | 63 | 63 | 63 | 63 | 63 | N | 201 | 201 | 201 | ||
| x̄ | 0.28 | 3.07 | 39.64 | 1.19 | 6.43 | x̄ | 3.05 | 7.14 | 35.71 | ||
| CV | 15.2 | 4.3 | 4.4 | 5.0 | 4.0 | CV | 5.6 | 3.2 | 3.7 | ||
| inter-laboratory: | |||||||||||
| 1 | 2 | 3 | 4 | ||||||||
| N | 8 | 8 | 8 | 8 | |||||||
| x̄ | 3.06 | 13.27 | 31.48 | 83.59 | |||||||
| CV | 5.56 | 5.12 | 4.42 | 2.64 | |||||||
| Sensitivity | Lower detection limit: | ||||||||||
| 0.05 ng/ml | Minimum detectable conc.: | ||||||||||
| 0.15 ng/ml | |||||||||||
| Assay range | |||||||||||
| (LDL to | |||||||||||
| highest | |||||||||||
| standard) | 0.05 ng/ml - 50 ng/ml | 0.15 ng/ml - 100 ng/ml | |||||||||
| Interfering | |||||||||||
| Substances | No interference up to: | No interference up to: | |||||||||
| hemoglobin | 700 mg/dl | 200 mg/dl | |||||||||
| bilirubin | 64.5 mg/dl | 25 mg/dl | |||||||||
| lipemia | 1250 mg/dl (Intralipid) | 2320 mg/dl |