(111 days)
Enzymun® Progesterone Assay (K931117)
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No
The device description details a standard immunoassay based on chemical reactions and light measurement, with results determined via a calibration curve. There is no mention of AI or ML in the description or the "Mentions AI, DNN, or ML" section.
No
This device is an immunoassay for the in vitro quantitative determination of progesterone, meaning it measures a substance in a sample (serum/plasma) from the body rather than treating a condition.
Yes
The "Intended Use / Indications for Use" states "Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma," which indicates the device is used to measure a biomarker (progesterone) to help diagnose or monitor a condition.
No
The device description details a laboratory immunoassay process involving chemical reagents, incubations, magnetic capture of microparticles, and chemiluminescent emission measurement using a photomultiplier. This clearly indicates a physical device with hardware components, not a software-only device.
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 progesterone in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based immunoassay process involving the analysis of biological samples (serum and plasma) using reagents and a measuring instrument. This is characteristic of an IVD.
- Performance Studies: The performance studies describe the evaluation of the device's ability to accurately measure progesterone in samples, which is essential for an IVD.
- Predicate Device: The mention of a predicate device (K931117; Enzymun® Progesterone Assay) which is also an immunoassay for progesterone, further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically other IVDs.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Competition principle. Total duration of assay: 18 minutes (37 °C). · Ist incubation (9 min.): 50 uL sample - in the presence of a progesterone-derivative labeled with a ruthenium complex(65 uL)** are incubated with Danazol to release progesterone.
After addition of biotinylated polyclonal ·2nd incubation (9 min.): progesterone-specific antibodies (50 uL) and streptavidin-coated microparticles (50 uL), progesterone from the sample competes with the labeled progesterone derivative for the antibody binding sites. At the same time the entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. The proportion of labeled progesterone derivative bound to the solid phase is inversely proportional to the progesterone content of the sample.
· 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)2+3)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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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:
Level: Low, Mid, High
N: 60 for each level
Within-Run:
Low: Mean: 3.1, %CV: 3.7
Mid: Mean: 7.8, %CV: 1.9
High: Mean: 88.2, %CV: 0.7
Total:
Low: Mean: 3.1, %CV: 6.8
Mid: Mean: 7.8, %CV: 3.1
High: Mean: 88.2, %CV: 0.8
Lower Detection Limit: 0.05 ng/mL
Linearity: 0.05-100 ng/mL (with a deviation from a linear line of ± 10%)
Method Comparison Vs Enzymun-Test® Progesterone:
Least Squares y = 1.04x + 0.165, r = 0.9914, SEE = 0.620, N = 53
Passing/Bablok y = 1.07x - 0.059, r = 0.9914, SEE = 0.349, N = 53
Interfering substances: No interference at: Bilirubin 25 mg/dL, Hemoglobin 0.6 g/dL, Lipemia 400 mg/dL, Biotin 30 ng/mL
Specificity (Level tested (nMol/L) % Cross-reactivity):
Testosterone: 4.7
§ 862.1620 Progesterone test system.
(a)
Identification. A progesterone test system is a device intended to measure progesterone (a female hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the ovaries or placenta.(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
Mar 2 4 1997
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| 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 Patricia M. Klimley 25 of 2/24/97 | |
| Date Prepared: December 2, 1996 | |
| 2. Device name | Proprietary name: Elecsys® Progesterone Assay |
| Common name: Electrochemiluminescence assay for the determination of progesterone. | |
| Classification name: System, Test, Progesterone | |
| 3. Predicate device | We claim substantial equivalence to the Enzymun® Progesterone Assay (K931117). |
| Continued on next page |
1
K9648341
510(k) Summary, Continued
- Device Description
Competition principle. Total duration of assay: 18 minutes (37 °C). · Ist incubation (9 min.): 50 uL sample - in the presence of a progesteronederivative labeled with a ruthenium complex(65 uL)** are incubated with Danazol to release progesterone.
After addition of biotinylated polyclonal ·2nd incubation (9 min.): progesterone-specific antibodies (50 uL) and streptavidin-coated microparticles (50 uL), progesterone from the sample competes with the labeled progesterone derivative for the antibody binding sites. At the same time the entire complex becomes bound to the solid phase via interaction of biotin and streptavidin. The proportion of labeled progesterone derivative bound to the solid phase is inversely proportional to the progesterone content of the sample.
· 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)2+3)
ર્ષ Intended use Immunoassay for the in vitro quantitative determination of progesterone in human serum and plasma.
Continued on next page
2
K9648841
510(k) Summary, Continued
- Comparison to predicate device
The Bochringer Mannheim Elecsys® Progesterone 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® Progesterone Assay (K931117).
The following table compares the Elecsys® Progesterone Assay with the predicate device, Enzymun-Test® Progesterone 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 progesterone
·Sample type: Serum and plasma
· Antibody: Same polyclonal progesterone antibody
•Solid phase binding principle: Streptavidin/Biotin
Differences:
| Feature | Elecsys® Progesterone | Enzymun® Progesterone |
|---|---|---|
| Assay | ||
| Standardization | Enzymun® Progesterone | ID-GC/MS |
| 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
510(k) Summary, Continued
Performance Characteristics:
Comparison to predicate device, cont
| Feature | Elecsys® Progesterone
Modified NCCLS (ng/mL): | | | Enzymun® Progesterone
Modified NCCLS (ng/mL): | | |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------|----------------------------|
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 60 | 60 | 60 |
| Within-Run:
Mean
%CV
Total: Mean
%CV | 3.1
3.7
3.1
6.8 | 7.8
1.9
7.8
3.1 | 88.2
0.7
88.2
0.8 | 0.7
13.3
0.7
22.4 | 2.6
3.6
2.6
5.9 | 24.3
2.3
24.3
2.6 |
| Lower Detection
Limit | 0.05 ng/mL | | | 0.4 ng/mL | | |
| Linearity | 0.05-100 ng/mL (with a
deviation from a linear line of
$\pm$ 10%) | | | 0.4-30 ng/mL (with a
deviation from a linear line
of $\pm$ 10%) | | |
| Method
Comparison | Vs Enzymun-Test®
Progesterone
Least Squares
y = 1.04x + 0.165
r = 0.9914
SEE = 0.620
N = 53
Passing/Bablok
y = 1.07x - 0.059
r = 0.9914
SEE = 0.349
N = 53 | | | Vs Enzymun-Test®
Progesterone
Least Squares
y = 1.01x + 0.27
r = 0.997
SEE = 0.717
N = 48 | | |
| Interfering
substances | No interference at:
Bilirubin 25 mg/dL
Hemoglobin 0.6 g/dL
Lipemia 400 mg/dL
Biotin 30 ng/mL | | | No interference at:
64.5 mg/dL
1 g/dL
250 mg/dL
50 ng/mL | | |
Continued on next page
4
K964841
510(k) Summary, Continued
Performance Characteristics:
રં.
Comparison to predicate device, cont
| Feature | Elecsys®
Progesterone | Enzymun®
Progesterone |
|--------------------------|-------------------------------------------------|-------------------------------------|
| Specificity | Level tested
(nMol/L) % Cross-
reactivity | Level tested % Cross-
reactivity |
| Testosterone | 4.7