(24 days)
Not Found
No
The description details a standard immunoassay based on chemical reactions and photometric measurement, with results determined via a calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or result generation.
No
This device is an immunoassay for the in vitro quantitative determination of a hormone, designed for diagnostic purposes, not for treating a disease or condition.
Yes
The device is described as an "Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone in human serum and plasma," which falls under the definition of a diagnostic device as it quantifies a specific analyte to aid in diagnosis.
No
The device description details a complex immunoassay process involving chemical reactions, microparticles, magnetic capture, and chemiluminescent emission measured by a photomultiplier. This clearly indicates the presence of significant hardware components and is 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 follicle stimulating hormone in human serum and plasma." The phrase "in vitro" is the key indicator that the test is performed outside of the living body, which is the definition of an in vitro diagnostic.
- Device Description: The description details a laboratory-based assay using biological samples (serum and plasma) and chemical reagents to measure a substance (FSH) within those samples. This is characteristic of an IVD.
- Performance Studies: The performance studies describe metrics relevant to laboratory testing of biological samples, such as precision, detection limit, linearity, and method comparison against another IVD.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of human follicle stimulating hormone 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.
• 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex.
•2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Precision: Modified NCCLS (mIU/mL):
Low: N=60, Within-Run Mean=1.20, %CV=1.75, Total Mean=1.20, %CV=5.26
Mid: N=60, Within-Run Mean=11.1, %CV=1.95, Total Mean=11.1, %CV=3.69
High: N=60, Within-Run Mean=103.0, %CV=1.80, Total Mean=103.0, %CV=5.08
Lower Detection Limit: 0.10 mIU/mL
Linearity: 0.10-200 mIU/mL (with a deviation from a linear line of ±10%)
Method Comparison Vs Enzymun-Test® FSH:
Least Squares y = 1.10x + 0.11, r = 0.998, SEE = 1.552, N = 160
Passing/Bablok y = 1.09x + 0.21, r = 0.998, SEE = 0.504, N = 160
Interfering substances: No interference at:
Bilirubin: 25 mg/dL
Hemoglobin: 1 g/dL
Lipemia: 1500 mg/dL
Biotin: 30 ng/mL
Rheumatoid Factor: 1500 IU/mL
Specificity:
LH: 1040 mIU/mL, % Cross-reactivity
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(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
DEC 1 6 1996
| K964693 | |
|---|---|
| -- | --------- |
10(k) SummaryMOWER TO THE POLICE ..
| 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 8240 | ||
| FAX 510 687 - 1850 | ||
| Contact Person: Betsy Soares-Maddox | ||
| Date Prepared: November 19, 1996 | ||
| 2. | ||
| Device name | Proprietary name: Elecsys® FSH Assay | |
| Common name: Electrochemiluminescence assay for the determination of human follicle stimulating hormone (FSH). | ||
| Classification name: System, Test, Human Follicle Stimulating Hormone | ||
| 3. | ||
| Predicate | ||
| device | We claim substantial equivalence to the Enzymun® FSH Assay (K900763). | |
| 4. | ||
| Device | ||
| Description | Sandwich principle. Total duration of assay: 18 minutes. | |
| • 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex. | ||
| •2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 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 |
Continued on next page
1
510(k) Summary, Continued
| 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 follicle
stimulating hormone in human serum and plasma. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® FSH 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®
FSH Assay (K900763). |
| | The following table compares the Elecsys® FSH Assay with the predicate
device, Enzymun® FSH 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 human follicle stimulating hormone (FSH) |
| | •Sample type: Serum and plasma |
| | • Antibody: Same pair of monoclonal mouse anti-FSH antibodies |
| | •Solid phase binding principle: Streptavidin/Biotin |
| | Continued on next page |
。
2
510(k) Summary, Continued
Comparison to predicate device cont.
Enzymun-Test® FSH Elecsys® FSH Feature WHO 78/549 Enzymun-Test® FSH Assay Standardization Electrochemiluminescence ELISA/1-step sandwich assay Detection method using streptavidin technology Instrument required | Elecsys® 2010 ES 300 Full calibration required every Calibration A calibration is recommended every 7 days 2 weeks. One-point Stability calibration required every run. if kit is not consumed; 4 weeks with same reagent
lot if reagent is consumed
within 7 days.
Performance Characteristics:
Differences (continued):
| Feature | Elecsys® FSH | Enzymun-Test® FSH | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (mIU/mL): | Modified NCCLS (mIU/mL): | ||||
| Level | Low | Mid | High | Low | Mid | High |
| N | ||||||
| Within-Run: Mean | ||||||
| %CV | ||||||
| Total: Mean | ||||||
| %CV | 60 | |||||
| 1.20 | ||||||
| 1.75 | ||||||
| 1.20 | ||||||
| 5.26 | 60 | |||||
| 11.1 | ||||||
| 1.95 | ||||||
| 11.1 | ||||||
| 3.69 | 60 | |||||
| 103.0 | ||||||
| 1.80 | ||||||
| 103.0 | ||||||
| 5.08 | 120 | |||||
| 8.7 | ||||||
| 2.1 | ||||||
| 8.7 | ||||||
| 2.3 | 119 | |||||
| 13.8 | ||||||
| 1.8 | ||||||
| 13.8 | ||||||
| 2.6 | 120 | |||||
| 30.7 | ||||||
| 1.2 | ||||||
| 30.7 | ||||||
| 3.1 | ||||||
| Lower Detection | ||||||
| Limit | 0.10 mIU/mL | 0.50 mIU/mL |
Continued on next page
3
510(k) Summary, Continued
Performance Characteristics:
Comparison
to predicate
device, (cont.)
| Feature | Elecsys® FSH | Enzymun-Test® FSH |
|---|---|---|
| Linearity | 0.10-200 mIU/mL (with a deviation from a linear line of ±10%) | 0.50-150 mIU/mL (with a deviation from a linear line of ±10%) |
| Method | ||
| Comparison | Vs Enzymun-Test® FSH | |
| Least Squares | ||
| $y = 1.10 + 0.11$ | ||
| $r = 0.998$ | ||
| $SEE = 1.552$ | ||
| $N = 160$ |
Passing/Bablok
$y = 1.09x + 0.21$
$r = 0.998$
$SEE = 0.504$
$N = 160$ | Vs Enzymun-Test® FSH
Least Squares
$y = 0.96x + 0.04$
$r = 0.993$
$SEE = 3.37$
$N = 76$ |
| Interfering
substances | No interference at: | No interference at: |
| Bilirubin | 25 mg/dL | 64.5 mg/dL |
| Hemoglobin | 1 g/dL | 1 g/dL |
| Lipemia | 1500 mg/dL | 1250 mg/dL |
| Biotin | 30 ng/mL | 90 ng/mL |
| Rheumatoid
Factor | 1500 IU/mL | no interference |
| Specificity | Level tested | % Cross-
reactivity |
| | % Cross-
reactivity | Level tested |
| LH | 1040 mIU/mL |