(56 days)
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No
The device description details a standard immunoassay using chemical reactions and a calibration curve for quantitative determination, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an immunoassay intended for the in vitro quantitative determination of human prolactin, which is a diagnostic function, not a therapeutic one. It measures a substance in the body rather than treating a condition.
Yes
The device is an "Immunoassay for the in vitro quantitative determination of human prolactin in human serum and plasma," which falls under the definition of a diagnostic device as it measures a substance in a biological sample to provide information that can be used for diagnosis.
No
The device description clearly outlines a laboratory immunoassay that involves physical reagents (antibodies, microparticles), incubation steps, magnetic capture, and chemiluminescent detection using a photomultiplier. This is a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "Immunoassay for the in vitro quantitative determination of human prolactin in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes human serum and plasma, which are biological samples taken from the body but tested outside of it.
- Measurement: It performs a "quantitative determination" of a specific analyte (prolactin) in these samples.
- Device Description: The description details a laboratory-based immunoassay process involving reagents, incubation, and measurement using a chemiluminescent method. This is typical of IVD devices used in clinical laboratories.
- Performance Studies: The document includes performance characteristics like precision, detection limit, linearity, and method comparison, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (K900695; Enzymun® Prolactin Assay) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device of the same type.
All these elements strongly point to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of human prolactin in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Sandwich principle. Total duration of assay: 18 minutes (37 °C).
• 1st incubation (9 min.): 10µL of sample, a biotinylated monoclonal prolactin- specific antibody (75 µL), and a monoclonal prolactin-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (40 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
**Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+3)
•The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
•Results are determined via a calibration curve which is instrument specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
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)
Precision:
Modified NCCLS (µIU/mL):
- Level: Low, Mid, High
- N: 60, 60, 60
- Within-Run: Mean: 229.8, 1843.5, 4662.1
- % CV: 2.4, 1.9, 2.4
- Total: Mean: 229.8, 1843.5, 4662.1
- % CV: 3.1, 3.4, 3.3
Lower Detection Limit: 10 µIU/mL
Linearity: 10-10,000 µIU/mL (with a deviation from a linear line of ±10%)
Method Comparison Vs Enzymun-Test® Prolactin:
Least Squares:
y = 1.14x - 33.36
r = 0.9986
SEE = 40.088
N = 99
Passing/Bablok:
y = 1.101x - 19.40
r = 0.9986
SEE = 9.001
N = 99
Interfering substances (No interference at):
Bilirubin: 25 mg/dL
Hemoglobin: 1 g/dL
Lipemia: 1500 mg/dL
Biotin: 30 ng/mL
Rheumatoid Factor: 1700 µIU/mL
Specificity:
Level tested / % Cross-reactivity
HGH: 200 mU/mL / 0.00
HPL: 100 ng/mL / 0.00
HCG: 1000 IU/mL / 0.00
TSH: 500 µIU/mL / 0.00
FSH: 2 IU/mL / 0.00
LH: 1 IU/mL / 0.00
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1625 Prolactin (lactogen) test system.
(a)
Identification. A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.(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 § 862.9.
0
1964748
JAN 2 1 1997
| 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 |
| 2400 Bisso Lane | |
| P.O. Box 4117 | |
| Concord, CA 94524-4117 | |
| (510) 674 - 0690 extension 8415 | |
| FAX 510 687 - 1850 | |
| Contact Person: Mary Koning | |
| Date Prepared: November 21, 1996 | |
| 2. | |
| Device name | Proprietary name: Elecsys® Prolactin Assay |
| Common name: Electrochemiluminescence assay for the determination of | |
| prolactin. | |
| Classification name: System, Test, Prolactin | |
| 3. | |
| Predicate | |
| device | We claim substantial equivalence to the Enzymun® Prolactin Assay |
| (K900695). | |
| 4. | |
| Device | |
| Description | Sandwich principle. Total duration of assay: 18 minutes (37 °C). |
| • 1st incubation (9 min.): 10µL of sample, a biotinylated monoclonal prolactin- | |
| specific antibody (75 µL), and a monoclonal prolactin-specific antibody | |
| labeled with a ruthenium complex (75 µL)** react to form a sandwich | |
| complex. | |
| •2nd incubation (9 min.): after addition of streptavidin-coated microparticles | |
| (40 µL), the complex becomes bound to the solid phase via interaction of | |
| biotin and streptavidin. | |
| **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)2+3) | |
| 4. | |
| Device | |
| Description | •The reaction mixture is aspirated into the measuring cell where the |
| microparticles are magnetically captured onto the surface of the electrode. | |
| Unbound substances are then removed with ProCell. Application of a voltage | |
| to the electrode then induces chemiluminescent emission which is measured | |
| by a photomultiplier (0.4 second read frame). | |
| •Results are determined via a calibration curve which is instrument | |
| specifically generated by 2-point calibration and a master curve provided via | |
| the reagent bar code. | |
| 5. | |
| Intended use | Immunoassay for the in vitro quantitative determination of human prolactin in |
| human serum and plasma. | |
| 6. | |
| Comparison | |
| to predicate | |
| device | The Boehringer Mannheim Elecsys® Prolactin Assay is substantially |
| equivalent to other products in commercial distribution intended for similar | |
| use. Most notably it is substantially equivalent to the currently marketed | |
| Enzymun® Prolactin Assay (K900695). |
The following table compares the Elecsys® Prolactin Assay with the
predicate device, Enzymun® Prolactin Assay. Specific data on the
performance of the test have been incorporated into the draft labeling in
attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination
of prolactin
•Sample type: Serum and plasma
•Antibody: Same pair of mouse monoclonal prolactin antibodies
•Solid phase binding principle: Streptavidin/Biotin
•Assay standardization: World Health Organization Standard (WHO)
#84/500 |
Continued on next page
!
,
1
510(k) Summary, Continued
.
.
:
ﺳﺴﺴﺴ
.
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: #
2
510(k) Summary, Continued
Differences:
Comparison
to predicate device cont.
| Feature | Elecsys® Prolactin | Enzymun-Test® Prolactin |
|---|---|---|
| Detection method | Electrochemiluminescence | ELISA/1-step sandwich |
| assay | ||
| Instrument required | Elecsys® 2010 | ES 300 |
| Calibration Stability | A calibration is | |
| recommended every 7 | ||
| days if kit is not | ||
| consumed; 4 weeks with | ||
| same reagent lot if reagent | ||
| is consumed within 7 | ||
| days. | Full calibration required | |
| every 2 weeks. One-point | ||
| calibration required every | ||
| run. |
Performance Characteristics:
| Feature | Elecsys® Prolactin | Enzymun-Test® Prolactin | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (µIU/mL): | Modified NCCLS (µIU/mL): | ||||
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 119 | 119 | 120 |
| Within-Run: Mean | 229.8 | 1843.5 | 4662.1 | 10.1 | 28.3 | 63.0 |
| % CV | 2.4 | 1.9 | 2.4 | 2.1 | 2.4 | 1.9 |
| Total: Mean | 229.8 | 1843.5 | 4662.1 | 10.1 | 28.3 | 63.0 |
| % CV | 3.1 | 3.4 | 3.3 | 4.5 | 2.7 | 2.2 |
| Lower Detection | ||||||
| Limit | 10 µIU/mL | 27.56 µIU/mL |
Continued on next page
3
510(k) Summary, Continued
..............................................................................................................................................................................
Performance Characteristics:
Comparison
to predicate device, (cont.)
| Feature | Elecsys® Prolactin | Enzymun-Test® Prolactin |
|---|---|---|
| Linearity | 10-10,000 µIU/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | 27.56-6,360 mIU/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | ||
| Method | ||
| Comparison | Vs Enzymun-Test® Prolactin | |
| Least Squares | ||
| $y = 1.14x - 33.36$ | ||
| $r = 0.9986$ | ||
| $SEE = 40.088$ | ||
| $N = 99$ |
Passing/Bablok
$y = 1.101x - 19.40$
$r = 0.9986$
$SEE = 9.001$
$N = 99$ | Vs Enzymun-Test® Prolactin
Least Squares
$y = 0.79x + 2.63$
$r = 0.996$
$SEE = 3.764$
$N = 76$ |
| Interfering
substances | No interference at: | No interference at: |
| Bilirubin | 25 mg/dL | 64.5 mg/dL |
| Hemoglobin | 1 g/dL | 1 mg/dL |
| Lipemia | 1500 mg/dL | 1250 mg/dL |
| Biotin | 30 ng/mL | 100 ng/mL |
| Rheumatoid
Factor | 1700 µIU/mL | no interference |
| Specificity | Level tested | % Cross-
reactivity |
| | Level tested | % Cross-
reactivity |
| HGH | 200 mU/mL | 0.00 |
| HPL | 100 ng/mL | 0.00 |
| HCG | 1000 IU/mL | 0.00 |
| TSH | 500 µIU/mL | 0.00 |
| FSH | 2 IU/mL | 0.00 |
| LH | 1 IU/mL | 0.00 |
| HGH | 2 mU/mL | 0.00 |
| HPL | 100 ng/mL | 0.00 |
| HCG | 625 IU/mL | 0.00 |
| TSH | 50 µIU/mL | 0.00 |
| FSH | 38 IU/mL | 0.00 |
| LH | 12.5 IU/mL | 0.00 |