(60 days)
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No
The description details a standard immunoassay based on chemical reactions and luminescence measurement. There is no mention of AI, ML, or any computational analysis beyond basic calibration and curve fitting.
No
Explanation: This device is an in vitro diagnostic test for measuring estradiol levels, not a device used for treating or preventing a disease.
Yes
Explanation: The device is an immunoassay for the quantitative determination of estradiol in human serum and plasma, which provides an objective measurement to aid in the diagnosis, monitoring, or assessment of a medical condition.
No
The device description clearly outlines a physical immunoassay process involving reagents, microparticles, magnetic capture, and chemiluminescent emission measurement, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based assay using biological samples (serum and plasma) and chemical reagents to measure a substance (estradiol) within those samples. This is the core function of an IVD.
- Performance Studies: The performance studies describe analytical characteristics like precision, detection limit, linearity, and method comparison, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K916132; Enzymun-Test® Estradiol Assay) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma.
Product codes
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Device Description
Competition principle. Total duration of assay: 18 minutes, 37 °C.
· 1st incubation (9 minutes): By incubating the sample (50 uL) with an estradiol-specific biotinylated antibody (65 uL), an immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample.
·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 µL) and an estradiol derivative labeled with a ruthenium complex* (65 uL), the still-vacant sites of the biotinylated antibodies become occupied, with the formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.
· 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 instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
** Tris(2,2'-bipyridy))ruthenium(II) complex (Ru(bpy)" 3)
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)
Performance Characteristics were reported for Precision, Lower Detection Limit, Linearity, Method Comparison, Interfering substances, and Specificity.
Precision:
Modified NCCLS (pg/mL):
Low (7.7 Mean, 9.0 %CV), Mid (44.0 Mean, 6.5 %CV), High (277.6 Mean, 9.1 %CV), High (3021 Mean, 10.3 %CV)
Lower Detection Limit: 10 pg/mL
Linearity: 10-1300 pg/mL (with a deviation from a linear line of ±10%) Vs Enzymun-Test Estradiol.
Method Comparison: Least Squares y = 1.027x + 6.32, r = 0.995, SEE = 31.03, N = 64. Passing/Bablok y = 0.962x + 12.51, r = 0.976, SEE = 38.71, N = 74.
No interference at: Bilirubin 64.5 mg/dL, Hemoglobin 200 mg/dL, Lipemia 1250 mg/dL, Biotin 20 ng/mL.
Specificity (% Cross-reactivity) levels tested at: 17 hydroxy-Progesterone
§ 862.1260 Estradiol test system.
(a)
Identification. An estradiol test system is a device intended to measure estradiol, an estrogenic steroid, in plasma. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.(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
| 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 8413 | |
| FAX (510) 687 - 1850 | |
| Contact Person: Yvette Lloyd | |
| Date Prepared: December 13, 1996 | |
| 2. | |
| Device name | Proprietary name: Elecsys® Estradiol Assay |
| Common name: Electrochemiluminescence assay for the determination of | |
| estradiol. | |
| Classification name: System, Test, Estradiol | |
| 3. | |
| Predicate | |
| device | We claim substantial equivalence to the Enzymun-Test® Estradiol Assay |
| (K916132). |
. . . . . .
: 上一
and the comments of the comments of
n
1
- Device Description Competition principle. Total duration of assay: 18 minutes, 37 °C.
· 1st incubation (9 minutes): By incubating the sample (50 uL) with an estradiol-specific biotinylated antibody (65 uL), an immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample.
·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 µL) and an estradiol derivative labeled with a ruthenium complex* (65 uL), the still-vacant sites of the biotinylated antibodies become occupied, with the formation of an antibody-hapten complex. The entire complex becomes bound to the solid phase via interaction of biotin and streptavidin.
· 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 instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
** Tris(2,2'-bipyridy))ruthenium(II) complex (Ru(bpy)" 3)
ડ. Intended use
Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma.
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2
- Comparison to predicate device
The Boehringer Mannheim Elecsys® Estradiol 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-Test® Estradiol Assay (K916132).
The following table compares the Elecsys® Estradiol Assay with the predicate device, Enzymun-Test® Estradiol 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 estradiol
·Sample type: Serum and plasma
· Antibody: Same polyclonal anti-estradiol antibody
· Solid phase binding principle: Streptavidin/Biotin
· Assay Standardization: ID-GC/MS
: -
Differences:
ﺔ ﺍﻟﻘ
, i
| Feature | Elecsys® Estradiol | Enzymun® Estradiol |
|---|---|---|
| Reaction test | ||
| principle | 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. |
Continued on next page
3
Performance Characteristics:
Comparison to predicate device, cont.
Enzymun® Estradiol Elecsys® Estradiol Feature Modified NCCLS (pg/mL): Modified NCCLS (pg/mL): Precision Mid High High Low Mid Low Level ୧୦ ୧୦ 60 ୧୦ ୧୦ N ୧୦ 1217.0 44.0 277.6 3021 ર 3.3 410 Within-Run: Mean 7.7 8 . ર 3.0 14.3 2.7 6.5 %CV 1217.0 277.6 3021 44.0 410 53.3 Total: Mean 9.1 10.3 ર રે 16.1 ર .0 %CV 9.0 10 pg/mL 10 pg/mL Lower Detection Limit 10-1300 pg/mL (with a 10-4600 pg/mL (with a Linearity deviation from a linear line deviation from a linear line ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ of ±10%) of ±10%) Vs Enzymun-Test Vs Enzymun-Test Method Estradiol Estradiol Comparison Least Squares Least Squares y = 1.027x + 6.32 y = 0.902x + 42.94 r = 0.995 r = 0.976 SEE = 31.03 SEE = 91.96 N = 64 N = 74 . Passing/Bablok y = 0.962x + 12.51 r = 0.976 SEE = 38.71 N = 74 No interference at: No interference at: Interfering substances 64.5 mg/dL 25 mg/dL Bilirubin 200 mg/dL 1.0 g/dL Hemoglobin 1250 mg/dL 1500 mg/dL Lipemia 20 ng/mL Biotin 24 ng/mL
Continued on next page
4
Performance Characteristics:
Comparison to predicate device, cont.
| Feature | Elecsys® Estradiol | Enzymun® Estradiol | ||
|---|---|---|---|---|
| Specificity | Level tested | |||
| (ng/mL) | % Cross- | |||
| reactivity | Level tested | % Cross- | ||
| reactivity | ||||
| 17 hydroxy-Progesterone | 100 |