(55 days)
Not Found
No
The description details a standard immunoassay based on chemical reactions and light detection, with results determined by a calibration curve. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
The device is an immunoassay for the quantitative determination of human chorionic gonadotropin, which is a diagnostic tool, not a device used for therapy.
Yes
The device's intended use is for the quantitative determination of human chorionic gonadotropin in human serum and plasma, which is a measurement used for diagnostic purposes (e.g., pregnancy detection, certain cancers). The "Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of human chorionic gonadotropin in human serum and plasma," indicating its use in assessing a patient's condition.
No
The device description details a complex immunoassay process involving chemical reactions, incubations, magnetic capture of microparticles, and chemiluminescent emission measurement. This clearly indicates the presence of physical hardware components and chemical reagents, not just software.
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 human chorionic gonadotropin in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a laboratory-based assay process involving the analysis of biological samples (serum and plasma) using reagents and instrumentation. This is characteristic of an IVD.
- Performance Studies: The document describes performance studies like precision, lower detection limit, linearity, and method comparison, which are standard evaluations for IVD devices.
- Predicate Device: The mention of a predicate device (K896901; Enzymun® HCG Assay) further confirms that this device is being compared to an existing IVD.
All of these elements strongly indicate that this device is designed to be used outside of the body to examine specimens for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of human chorionic gonadotropin in human serum and plasma.
Product codes
Not Found
Device Description
The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C). • 1st incubation (9 minutes): Sample (15 µL), a biotinylated HCG specific antibody (75 µL), and a specific anti-HCG antibody labeled with a ruthenium complex (75 µL). •2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 µL), the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is 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 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
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Anatomical Site
Not Found
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 (mIU/mL):
- Level: Serum, N=60, Within-Run %CV = 24.80, %CV = 4.5, Total %CV = 24.80, %CV = 5.8
- Level: Control 1, N=60, Within-Run %CV = 35.39, %CV = 3.3, Total %CV = 35.39, %CV = 3.9
- Level: Control 2, N=60, Within-Run %CV = 854.30, %CV = 2.7, Total %CV = 854.30, %CV = 4.5
Precision (Enzymun® HCG): Modified NCCLS (µg/dL): - Level: Low, N=58, Within-Run %CV = 19.9, %CV = 4.6, Total %CV = 19.9, %CV = 5.7
- Level: Mid, N=58, Within-Run %CV = 181.5, %CV = 2.9, Total %CV = 181.5, %CV = 4.6
- Level: High, N=53, Within-Run %CV = 593.8, %CV = 3.1, Total %CV = 593.8, %CV = 4.1
Lower Detection Limit: 0.5 mIU/mL (Elecsys® HCG), 1.5 mIU/mL (Enzymun® HCG)
Linearity: Elecsys® HCG: 0.5 - 1,000 mIU/mL (with a deviation from a linear line of ±10%), Enzymun® HCG: 1.5 - 600 mIU/mL (with a deviation from a linear line of ±10%)
Method Comparison vs Enzymun-Test® HCG: - Elecsys® HCG: Least Squares y=1.35x - 9.21, r=0.989, SEE=17.50, N=64. Passing/Bablok y=1.29x - 4.05, r=0.989, SEE=17.50, N=64
- Enzymun® HCG: Least Squares y =1.047x - 4.92, r=0.996, SEE =13.056, N=49
Interfering substances: - Elecsys® HCG: No interference at: Bilirubin 25 mg/dL, Hemoglobin 1 g/dL, Lipemia 1500 mg/dL, Biotin 30 ng/mL
- Enzymun® HCG: No interference at: 51.7 mg/dL, 1 g/dL, 1250 mg/dL, 200 ng/mL
Specificity: % Cross-reactivity - LH: Elecsys® HCG: Level tested 1000 mIU/mL, % Cross-reactivity 0.07. Enzymun® HCG: Level tested 400 mIU/mL, % Cross-reactivity 0.15
- FSH: Elecsys® HCG: Level tested 1000 mIU/mL, % Cross-reactivity 0.09. Enzymun® HCG: Level tested 400 mIU/mL, % Cross-reactivity 0.28
- TSH: Elecsys® HCG: Level tested 2500 mIU/mL, % Cross-reactivity 0.000. Enzymun® HCG: Level tested 2000 mIU/mL, % Cross-reactivity 5.0
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Image /page/0/Picture/1 description: The image shows the word "Diagnostics" in a serif font. To the left of the word is a dark square with some text in it. The text in the square includes the number 1981.
JUN 1 2 1996
【,】【
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 |
|---|---|
| Contact Person: Mary Koning Date Prepared: April 9, 1996 | |
| 2. Device name | Proprietary name: Elecsys® HCG Assay Common name: Electrochemiluminescence assay for the determination of human chorionic gonadotropin (HCG). Classification name: System, Test, Human Chorionic Gonadotropin |
| 3. Predicate device | We claim substantial equivalence to the Enzymun® HCG Assay(K896901). |
| 4. Device Description | The Elecsys® test principle is based on competition principle. Total duration of assay: 18 minutes (37° C). • 1st incubation (9 minutes): Sample (15 µL), a biotinylated HCG specific antibody (75 µL), and a specific anti-HCG antibody labeled with a ruthenium complex (75 µL). •2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 µL), the still-free binding sites of the labeled antibody become occupied, with formation of an antibody-hapten complex. The entire complex is bound to the solid phase via interaction of biotin and streptavidin. |
Continued on next page
1
Image /page/1/Picture/0 description: The image shows the word "Diagnostics" in a serif font. The word is in black and is positioned to the right of a black square. The text is slightly slanted to the right. There is some additional text below the word, but it is not clear.
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 chorionic
gonadotropin in human serum and plasma. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Elecsys® HCG 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®
HCG Assay (K896901). |
| | The following table compares the Elecsys® HCG Assay with the predicate
device, Enzymun® HCG 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 chorionic gonadotropin (HCG) |
| | •Sample type: Serum and plasma |
| | •Antibody: Polyclonal Sheep anti-HCG antibodies |
| | •Solid phase binding principle: Streptavidin/Biotin |
| | •Assay standardization: World Health Organization Standard (WHO)
75/537 (1st IRP). |
| | Continued on next page |
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510(k) Summary, Continued
Comparison
to predicate
device cont.
Differences:
| Feature | Elecsys® HCG | Enzymun® HCG |
|---|---|---|
| Reaction test | ||
| principle | 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. | Calibration required every run |
Performance Characteristics:
| Feature | Elecsys® HCG | Enzymun® HCG | |||||
|---|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (mIU/mL): | Modified NCCLS (µg/dL): | |||||
| Level | Serum | Control 1 | Control 2 | Low | Mid | High | |
| N | 60 | 60 | 60 | 58 | 58 | 53 | |
| Within-Run %CV | 24.80 | 35.39 | 854.30 | 19.9 | 181.5 | 593.8 | |
| %CV | 4.5 | 3.3 | 2.7 | 4.6 | 2.9 | 3.1 | |
| Total %CV | 24.80 | 35.39 | 854.30 | 19.9 | 181.5 | 593.8 | |
| %CV | 5.8 | 3.9 | 4.5 | 5.7 | 4.6 | 4.1 | |
| Lower Detection Limit | 0.5 mIU/mL | 1.5 mIU/mL |
Continued on next page
3
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510(k) Summary, Continued
Performance Characteristics:
参考文献
Comparison
to predicate
device, (cont.)
| Feature | Elecsys® HCG | Enzymun® HCG |
|---|---|---|
| Linearity | 0.5 - 1,000 mIU/mL (with a deviation from a linear line of ±10%) | 1.5 - 600 mIU/mL (with a deviation from a linear line of ±10%) |
| Method | ||
| Comparison | Vs Enzymun-Test® HCG | |
| Least Squares | ||
| $y=1.35x - 9.21$ | ||
| $r=0.989$ | ||
| SEE=17.50 | ||
| N=64 |
Passing/Bablok
$y=1.29x - 4.05$
$r=0.989$
SEE=17.50
N=64 | Vs Enzymun-Test® HCG
Least Squares
$y =1.047x - 4.92$
$r=0.996$
SEE =13.056
N=49 |
| Interfering
substances | No interference at:
Bilirubin 25 mg/dL
Hemoglobin 1 g/dL
Lipemia 1500 mg/dL
Biotin 30 ng/mL | No interference at:
51.7 mg/dL
1 g/dL
1250 mg/dL
200 ng/mL |
| Specificity | Level tested
(mIU/mL)
% Cross-
reactivity | Level tested
(mIU/mL)
% Cross-
reactivity |
| LH | 1000
0.07 | 400
0.15 |
| FSH | 1000
0.09 | 400
0.28 |
| TSH | 2500
0.000 | 2000
5.0 |