(252 days)
No
The summary describes a traditional immunofluorescence assay kit and its performance characteristics. There is no mention of AI, ML, image processing, or any computational analysis of the fluorescence images beyond visual interpretation by a trained user.
No
The device is described as an "aid in the diagnosis" and does not directly treat or manage a disease state. It is an in vitro diagnostic (IVD) device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis".
No
The device description clearly outlines a physical test kit containing slides, reagents, controls, and other tangible components, 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 it's for the "qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a medical condition (autoimmune encephalitis).
- Device Description: The description details a test kit containing reagents and components used to perform a laboratory assay on human serum samples.
- Input Imaging Modality: It uses a fluorescence microscope, which is a common tool for analyzing biological samples in a laboratory setting.
- Intended User / Care Setting: It's intended for use in "Laboratories familiar with indirect immunofluorescence," indicating a clinical or research laboratory environment.
- Performance Studies: The document includes performance studies (sensitivity and specificity) based on testing human serum samples, which is typical for IVD devices.
All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
N/A
Intended Use / Indications for Use
The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings.
Product codes
ેટਾਰ, OSK
Device Description
The EUROIMMUN IFA is an assay for standardized detection of anti-glutamate receptor (type NMDA) antibodies utilized in each laboratories familiar with indirect immunofluorescence. The non-transfected cells are used as a control to simplify differentiation of potential co-existing and non-specific reactivity such as ANA. The test kit consists of slides, which contain BIOCHIPs coated with glutamate receptor (type NMDA) transfected cells and non-transfected cells, fluorescein-labelled anti-human IgG (goat), a positive control for transforced volle and non new and of a negative control, a salt for preparation of PBS, Tween 20, embedding medium, cover glasses and an instruction booklet.
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)
Analytical performance:
a. Precision/Reproducibility:
Intra-assay reproducibility: The intra-assay reproducibility was determined by 10fold repeated measurements of 6 characterized positive and negative serum samples. The results did not exceed the acceptable deviation of fluorescence intensity of +/- 1 intensity level.
Inter-assay reproducibility: The inter-assay reproducibility was determined by repeated measurements of 6 characterized positive and negative serum samples at 5 different times. 2 slides were tested with each run. The results did not exceed the acceptable deviation of fluorescence intensity of +/- 1 intensity level.
Lot to lot reproducibility: The inter-lot reproducibility was determined by measurements of 3 characterized positive and negative serum samples using 3 different kit lots. The results did not exceed the acceptable deviation of fluorescence intensity of +/- 1 intensity level.
e. Analytical specificity:
Cross-reactivity: Cross reactivity was investigated using 31 samples from patients with infectious and autoimmune encephalitis other than anti-qlutamate receptor (type NMDA) encephalitis. Samples positive for anti-GluR2, anti-VGKC and anti-zic4 (cerebellar degeneration) do not react with the qlutamate receptor (type NMDA).
Interference: Three different samples are spiked with potential interfering substances in 3 different concentrations and are incubated with the test system. The recovery in relation to the original sample (not spiked) is calculated. The deviation in fluorescence intensity level did not exceed +/- 1. No interference was observed with hemolytic, lipemic or icteric samples for concentrations of up to 500 mg/dl for hemoglobin, 2000 mg/dl for triglyceride and 40 mg/dl for bilirubin.
Clinical studies:
Study 1: 47 serum samples from the US from patients diagnosed with anti-gluatamate receptor (type NMDA) encephalitis and controls with other encephalopathies, including anti-VGKC and AMPA receptor encephalitis, were examined. The panel comprised samples from 7 men and 40 women with an average age of 17 years (age range: 5 to 42 years; 1 unknown). In addition, sera of 100 adult healthy blood donors of mixed age and sex from Germany were analyzed. All samples from patients with anti-qlutamate receptor (type NMDA) encephalitis (29 sera) were tested positive with the transfected cells, while all disease control samples (18 sera) and healthy blood donors (100 sera) were negative.
Study 2: In a retrospective study, 2990 patients were screened for clinical symptoms of encephalitis of unknown origin. 5 of 6 samples fulfilling the criteria (6 women with an average age of 23 years, age range: 18 to 31 years; origin: Germany) were found positive for antibodies against glutamate receptor (type NMDA). The results support the fact that anti-glutamate receptor (type NMDA) encephalitis is a very frequent cause among these patients.
Study 3: 8 samples from patients with anti-glutamate receptor (type NMDA) encephalitis (origin: Germany) were investigated. The panel comprised samples from 3 men and 5 women with an average age of 25 years (age range: 16 to 39 years). All samples were found positive for antiqlutamate receptor (tpye NMDA).
Study 4: 9 samples from patients with anti-glutamate receptor (type NMDA) encephalitis and 13 samples from patients with other encephalopathies (origin: Italy) were investigated. The panel comprised samples from 8 men and 14 women with an average age of 47 years (age range: 9 to 89 years). All samples from patients with anti-glutamate receptor (type NMDA) encephalitis (9 sera) were tested positive with the transfected cells, while all disease control samples (13 sera) were negative.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall sensitivity: 98.1% (89.7 - 100.0% 95% C.I.)
Overall specificity: 100.0% (97.2 - 100.0% 95% C.I.)
Predicate Device(s)
Reference Device(s)
K051489, K061408, K070763, K083850
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
EUROIMMUN US INC.
Image /page/0/Picture/1 description: The image shows the text 'K100017' written in black ink. The text is positioned above a black graphic consisting of two horizontal lines with four black circles placed between them. The circles are evenly spaced along the lines, creating a visual pattern.
PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY (as required by 21 CFR § 807.92)
- A. 510(k)Number: K010017
- Purpose for Submission: B.
- New device C. Measurand:
- Autoantibodies against glutamate receptor (type NMDA)
- D. Type of Test:
- Semi-quantitative indirect immunofluorescent antibody assay
- E. Applicant:
- EUROIMMUN US INC.
- Proprietary and Established Names: E. EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA
- G. Regulatory Information:
-
- Requlation:
- 21 CFR 866.5660 Multiple autoantibodies immunological test system
-
- Classification: Class II
-
- Product code: ેટાર
-
- Panel:
-
Immunology
H. Intended Use:
-
Intended use(s): 1.
The EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA is intended for the qualitative determination of autoantibodies against glutamate receptor (type NMDA) in human serum. It is used as an aid in the diagnosis of anti-glutamate receptor (type NMDA) autoimmune encephalitis in conjunction with other laboratory and clinical findings. -
- Indication(s) for use: Same as intended use.
-
Special conditions for the use statement(s): 3.
-
For prescription use only.
-
Special instrument requirements: 4. Fluorescence microscope.
Device Description: l.
The EUROIMMUN IFA is an assay for standardized detection of anti-glutamate receptor (type NMDA) antibodies utilized in each laboratories familiar with indirect immunofluorescence. The non-transfected cells are used as a control to simplify differentiation of potential co-existing and non-specific reactivity such as ANA. The test kit consists of slides, which contain BIOCHIPs coated with glutamate receptor (type NMDA) transfected cells and non-transfected cells, fluorescein-labelled anti-human IgG (goat), a positive control for transforced volle and non new and of a negative control, a salt for preparation of PBS, Tween 20, embedding medium, cover glasses and an instruction booklet.
SEP 1 8 2010
1
Image /page/1/Picture/1 description: The image shows a black and white illustration of a ladder. The ladder has two long, horizontal rails on the top and bottom. There are four rungs connecting the two rails.
J. Substantial Equivalence Information:
- Predicate device name (s): 1. EUROIMMUN ANCA IFA Granulocyte BIOCHIP Mosaic™ Test System.
- Predicate 510(k) number(s): 2.
- K083850
-
- Comparison with predicate:
The EUROIMMUN ANCA IFA Granulocyte BIOCHIP Mosaic™ Test System was choosen as a device of equivalent method and technology. There is no exact predicate device available for the detection of antibodies against glutamate receptor (type NMDA).
| Similarities | ||||||
|---|---|---|---|---|---|---|
| Item | New device | Predicate device | ||||
| Intended Use | Semi-quantitative detection of antibodies | |||||
| in human serum. | Same | |||||
| Technology | IFA | |||||
| BIOCHIP TITERPLANE technology | ||||||
| using multiple substrates | Same | |||||
| Procedure | Standard IFA technique; serum | |||||
| incubation with tissues/cells, followed by | ||||||
| a wash step, incubation with fluorescein- | ||||||
| labelled anti-human globulin, wash step, | ||||||
| embedding and reading fluorescence | ||||||
| with a fluorescence microscope. | Same | |||||
| Reagent | Fluorescein | Same | ||||
| Sample type and | ||||||
| dilution | Serum | |||||
| 1:10 dilution | Same | |||||
| Controls | Positive control | |||||
| Negative control | Same | |||||
| Cut Off Level | 1:10 dilution | Same | ||||
| Differences | ||||||
| Intended Use | Detection of antibodies against | |||||
| glutamate receptor (type NMDA) | Detection of anti-neutrophil cytoplasmic | |||||
| antibodies (ANCA) |
Standard/Guidance Document Referenced (if applicable): K.
cells
Glutamate receptor (type NMDA)
transfected cells and non-transfected
None referenced.
L. Test Principle:
Substrates
The procedure follows the TITERPLANE Technique developed by EUROIMMUN as an aid in standardize immunological analyses. The TITERPLANE Technique of EUROIMMUN was cleared previously via the FDA 510(k) processes under 510(k) No. K051489, K061408, K070763 and K083850.
Human granulocytes native antigen
Patient samples, controls and in separate steps conjugate and embedding medium are applied to the reaction fields of a reagent tray. The BIOCHIP slides are then placed into the recesses of the reagent tray, where all nold of a reagen the slide comact with the fluids, and the individual reactions commence simultaneously. The fluids are confined to the recessed wells eliminating the need to use a conventional "humidity chamber".
Patient samples are diluted 1:10 in PBS-Tween, 25 µl of each diluted patient sample are added to each reaction field of the reagent tray. Reactions are started by fitting the BIOCHIP slides containing the substrates reachion hold of the reagon traym rype NMDA transfected cells and non-transfected cells) into the corresponding recesses of the reagent tray and incubated for 30 minutes at room temperature. into the other antigens. After incubation the BIOCHIP slides are washed with PBS-Tween to opecific antibodies. In the meantime, 20 ul of fluorescein-labelled anti-human globulin are added to remove unbodne antibodios. In the means, the BIOCHIP slides placed into the recesses of the tray. After a
2
30 minutes incubation at room temperature, the BIOCHIPs are again washed with PBS-Tween to remove any unbound fluorescein-labelled reagent. 10 ul of Embedding medium are placed for each reaction field on a cover glass and the BIOCHIP slides, with the BIOCHIPs facing downwards, placed onto the prepared cover glass. Fluorescence is read with a fluorescence microscope.
M. Performance Characteristics (where applicable):
Analytical performance: 1.
- a. Precision/Reproducibility:
- Intra-assay reproducibility
The intra-assay reproducibility was determined by 10fold repeated measurements of 6 characterized positive and negative serum samples. The results did not exceed the acceptable deviation of fluorescence intensity of +/- 1 intensity level.
Inter-assay reproducibility
The inter-assay reproducibility was determined by repeated measurements of 6 characterized positive and negative serum samples at 5 different times. 2 slides were tested with each run. The results did not exceed the acceptable deviation of fluorescence intensity of +/- 1 intensity level. Lot to lot reproducibility
The inter-lot reproducibility was determined by measurements of 3 characterized positive and negative serum samples using 3 different kit lots. The results did not exceed the acceptable deviation of fluorescence intensity of +/- 1 intensity level.
- b. Linearity/assay reportable range: Not applicable.
- Traceability, Stability, Expected values (controls, calibrators or methods): C.
There is no recognized standard or reference material for autoantibodies against glutamate receptor (type NMDA).
-
d. Detection limit:
Not applicable. -
Analytical specificity: e.
Cross-reactivity: Cross reactivity was investigated using 31 samples from patients with infectious and autoimmune encephalitis other than anti-qlutamate receptor (type NMDA) encephalitis. Samples positive for anti-GluR2, anti-VGKC and anti-zic4 (cerebellar degeneration) do not react with the qlutamate receptor (type NMDA).
Interference: Three different samples are spiked with potential interfering substances in 3 different concentrations and are incubated with the test system. The recovery in relation to the original sample (not spiked) is calculated. The deviation in fluorescence intensity level did not exceed +/- 1. No interference was observed with hemolytic, lipemic or icteric samples for concentrations of up to 500 mg/dl for hemoglobin, 2000 mg/dl for triglyceride and 40 mg/dl for bilirubin.
-
f. Assay cut-off:
Not applicable. -
- Comparison studies:
- Method comparison with predicate device: a. Not applicable.
- b. Matrix comparison: Not applicable.
3
Image /page/3/Picture/1 description: The image shows a pattern of alternating black and white shapes. There are four black shapes that are separated by white spaces. The black shapes are connected by two horizontal black lines at the top and bottom of the image.
3. Clinical studies:
Prevalence and specificity: a.
Study 1: 47 serum samples from the US from patients diagnosed with anti-gluatamate receptor (type NMDA) encephalitis and controls with other encephalopathies, including anti-VGKC and AMPA receptor encephalitis, were examined. The panel comprised samples from 7 men and 40 women with an average age of 17 years (age range: 5 to 42 years; 1 unknown). In addition, sera of 100 adult healthy blood donors of mixed age and sex from Germany were analyzed. All samples from patients with anti-qlutamate receptor (type NMDA) encephalitis (29 sera) were tested positive with the transfected cells, while all disease control samples (18 sera) and healthy blood donors (100 sera) were negative.
Study 2: In a retrospective study, 2990 patients were screened for clinical symptoms of encephalitis of unknown origin. 5 of 6 samples fulfilling the criteria (6 women with an average age of 23 years, age range: 18 to 31 years; origin: Germany) were found positive for antibodies against glutamate receptor (type NMDA). The results support the fact that anti-glutamate receptor (type NMDA) encephalitis is a very frequent cause among these patients.
Study 3: 8 samples from patients with anti-glutamate receptor (type NMDA) encephalitis (origin: Germany) were investigated. The panel comprised samples from 3 men and 5 women with an average age of 25 years (age range: 16 to 39 years). All samples were found positive for antiqlutamate receptor (tpye NMDA).
Study 4: 9 samples from patients with anti-glutamate receptor (type NMDA) encephalitis and 13 samples from patients with other encephalopathies (origin: Italy) were investigated. The panel comprised samples from 8 men and 14 women with an average age of 47 years (age range: 9 to 89 years). All samples from patients with anti-glutamate receptor (type NMDA) encephalitis (9 sera) were tested positive with the transfected cells, while all disease control samples (13 sera) were negative.
| Panel | n | EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA | |||
|---|---|---|---|---|---|
| positive | % positive | 95% C.I. | |||
| Study 1 | Patients with anti-glutamate receptor | ||||
| (type NMDA) encephalitis | 29 | 29 | 100.0% | 88.1 - 100.0% | |
| Patients with other encephalopathies | 18 | 0 | 0.0% | 0.0 - 18.5% | |
| Healthy blood donors | 100 | 0 | 0.0% | 0.0 - 3.6% | |
| Study 2 | Patients with encephalitis of unknown | ||||
| origin | 6 | 5 | 83.3% | 35.9 - 99.6% | |
| Study 3 | Patients with anti-glutamate receptor | ||||
| (type NMDA) encephalitis | 8 | 8 | 100.0% | 63.1 - 100.0% | |
| Study 4 | Patients with anti-glutamate receptor | ||||
| (type NMDA) encephalitis | 9 | 9 | 100.0% | 66.4 - 100.0% | |
| Patients with other encephalopathies | 13 | 0 | 0.0% | 0.0 - 24.7% | |
| Overall sensitivity | 52 | 51 positive | 98.1% | 89.7 - 100.0% | |
| Overall specificity | 131 | 131 negative | 100.0% | 97.2 - 100.0% |
Other clinical supportive data (when a. and b. are not applicable): b. Not applicable.
- Clinical cut-off: 4.
See Assay cut-off.
Expected values/Reference range: 5.
The levels of the anti-glutamate receptor (type NMDA) antibodies (IgG) were analyzed with the EUROIMMUN Anti-Glutamate receptor (type NMDA) IFA in a panel of 120 sera from normal healthy adult blood donors of mixed age and gender. All samples were found negative. The reference range was determined as titer 1: