(63 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, ML, or any computational learning processes.
No
This device is for in vitro quantitative determination of a hormone, indicating a diagnostic rather than therapeutic purpose.
Yes
The "Intended Use / Indications for Use" states that the device is an "Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma," which is a diagnostic purpose.
No
The device description clearly outlines a physical immunoassay process involving reagents, microparticles, magnetic capture, and chemiluminescent emission measured by a photomultiplier. This indicates a hardware-based system, 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 luteinizing hormone 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 reagents to measure a substance (luteinizing hormone) outside of the living body. This is the core function of an IVD.
- Performance Studies: The performance characteristics described (Precision, Lower Detection Limit, Linearity, Method Comparison, Interfering substances, Specificity) are all standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K900799) and name (Enzymun® LH Assay) strongly suggests that this device is being compared to a previously cleared IVD device, which is a common pathway for regulatory submission of new IVDs.
All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of human luteinizing hormone in human serum and plasma.
Product codes
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Device Description
Sandwich principle. Total duration of assay: 18 minutes.
• 1st incubation (9min.): 20 µL of sample, a biotinylated monoclonal LH-specific antibody (75 µL) and a monoclonal LH-specific antibody labeled with a ruthenium complex (75 µL)** react to form a sandwich complex.
• 2nd incubation (9min.): 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)3)2+)
•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
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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
Precision: Modified NCCLS (mIU/mL):
- Elecsys® LH:
- Low Level: N=60, Within-Run Mean=0.54, %CV=1.82; Total Mean=0.54, %CV=5.17
- Mid Level: N=60, Within-Run Mean=9.38, %CV=1.13; Total Mean=9.38, %CV=1.97
- High Level: N=60, Within-Run Mean=50.72, %CV=0.81; Total Mean=50.72, %CV=1.99
- Enzymun-Test® LH (Predicate):
- Low Level: N=120, Within-Run Mean=3.6, %CV=2.9; Total Mean=3.6, %CV=4.4
- Mid Level: N=120, Within-Run Mean=13.5, %CV=3.8; Total Mean=13.5, %CV=4.7
- High Level: N=120, Within-Run Mean=59.5, %CV=1.5; Total Mean=59.5, %CV=3.9
Lower Detection Limit:
- Elecsys® LH: 0.10 mIU/mL
- Enzymun-Test® LH: 0.50 mIU/mL
Linearity:
- Elecsys® LH: 0.1 - 200 mIU/mL (with a deviation from a linear line of ±10%)
- Enzymun-Test® LH: 0.5 - 150 mIU/mL (with a deviation from a linear line of ±10%)
Method Comparison Vs Enzymun-Test® LH:
- Elecsys® LH:
- Least Squares: y = 1.00x - 0.199, r = 0.993, SEE = 1.141, N = 166
- Passing/Bablok: y = 0.964x + 0.040, r = 0.993, SEE = 0.456, N = 166
- Enzymun-Test® LH:
- Least Squares: y = 0.93x + 0.42, r = 0.953, SEE = 5.079, N = 62
Interfering substances: No interference at:
- Elecsys® LH: Bilirubin 25.0 mg/dL, Hemoglobin 1 g/dL, Lipemia 1500 mg/dL, Biotin 30 ng/mL, Rheumatoid Factor 1500 U/mL
- Enzymun-Test® LH: Bilirubin 64.5 mg/dL, Hemoglobin 1 g/dL, Lipemia 1250 mg/dL, Biotin 40 ng/mL, no interference for Rheumatoid Factor
Specificity:
- Elecsys® LH:
- FSH: 300 mIU/mL,
§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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
JAN 2 4 1997
| Image: Boehringer Mannheim Corporation logo and K964694 | |
|---|---|
| 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® LH Assay |
| Common name: Electrochemiluminescence assay for the determination of | |
| human luteinizing hormone (LH). | |
| Classification name: System, Test, Human Luteinizing Hormone | |
| 3. | |
| Predicate | |
| device | We claim substantial equivalence to the Enzymun® LH Assay (K900799). |
| 4. | |
| Device | |
| Description | Sandwich principle. Total duration of assay: 18 minutes. |
| • 1st incubation (9min.): 20 µL of sample, a biotinylated monoclonal LH- | |
| specific antibody (75 µL) and a monoclonal LH-specific antibody labeled with | |
| a ruthenium complex (75 µL)** react to form a sandwich complex. | |
| • 2nd incubation (9min.): 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)3)2+) | |
| 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 luteinizing |
| hormone in human serum and plasma. | |
| 6. | |
| Comparison | |
| to predicate | |
| device | The Boehringer Mannheim Elecsys® LH 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® | |
| LH Assay (K900779). | |
| The following table compares the Elecsys® LH Assay with the predicate | |
| device, Enzymun® LH 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 luteinizing hormone (LH) | |
| •Sample type: Serum and plasma | |
| • Antibody: Same pair of monoclonal mouse anti-LH antibodies | |
| •Solid phase binding principle: Streptavidin/Biotin | |
| Continued on next page |
:
一一
..............................................................................................................................................................................
1
510(k) Summary, Continued
!
: . "
2
510(k) Summary, Continued
Differences:
Comparison
to predicate
device cont.
| Feature | Elecsys® LH | Enzymun-Test® LH |
|---|---|---|
| Assay | ||
| Standardization | Enzmun® LH | WHO # 80/552 |
| Detection method | Electrochemiluminescence | ELISA/1-step sandwich |
| assay using streptavidin | ||
| technology | ||
| Instrument | ||
| required | Elecsys® 2010 | ES 300 |
| Calibration | ||
| Stability | A calibration is recommended | |
| every 7 days if kits 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. |
mance Characteristics:
| Feature | Elecsys® LH | Enzymun-Test® LH | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (mIU/mL): | Modified NCCLS (mIU/mL): | ||||
| Level | Low | Mid | High | Low | Mid | High |
| N | 60 | 60 | 60 | 120 | 120 | 120 |
| Within-Run Mean | 0.54 | 9.38 | 50.72 | 3.6 | 13.5 | 59.5 |
| %CV | 1.82 | 1.13 | 0.81 | 2.9 | 3.8 | 1.5 |
| Total Mean | 0.54 | 9.38 | 50.72 | 3.6 | 13.5 | 59.5 |
| %CV | 5.17 | 1.97 | 1.99 | 4.4 | 4.7 | 3.9 |
| Lower Detection | ||||||
| Limit | 0.10 mIU/mL | 0.50 mIU/mL |
Continued on next page
3
510(k) Summary, Continued
l
Performance Characteristics:
.
Comparison
to predicate
device, (cont.)
| Feature | Elecsys® LH | Enzymun-Test® LH |
|---|---|---|
| Linearity | 0.1 - 200 mIU/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | 0.5 - 150 mIU/mL (with a | |
| deviation from a linear line of | ||
| ±10%) | ||
| Method | ||
| Comparison | Vs Enzymun-Test® LH | |
| Least Squares | ||
| $y = 1.00x - 0.199$ | ||
| $r = 0.993$ | ||
| $SEE = 1.141$ | ||
| $N = 166$ |
Passing/Bablok
$y = 0.964x + 0.040$
$r = 0.993$
$SEE = 0.456$
$N = 166$ | Vs Enzymun-Test® LH
Least Squares
$y = 0.93x + 0.42$
$r = 0.953$
$SEE = 5.079$
$N = 62$ |
| Interfering
substances | No interference at: | No interference at: |
| Bilirubin | 25.0 mg/dL | 64.5 mg/dL |
| Hemoglobin | 1 g/dL | 1 g/dL |
| Lipemia | 1500 mg/dL | 1250 mg/dL |
| Biotin | 30 ng/mL | 40 ng/mL |
| Rheumatoid
Factor | 1500 U/mL | no interference |
| Specificity | Level tested % Cross-
reactivity | Level tested % Cross-
reactivity |
| FSH | 300 mIU/mL