(406 days)
Not Found
No
The summary describes a standard ELISA test kit and its performance characteristics, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic test used for the detection of autoantibodies to aid in diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" states that the test kit is "used as an aid in the diagnosis of autoimmune hepatitis, type 2."
No
The device description clearly outlines a physical test kit with components like microwell plates, calibrators, controls, and various solutions, 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 detection of IgG class autoantibodies against LKM-1... in human serum and plasma." This indicates it's used to test samples taken from the human body.
- Device Description: The description details a "microwell ELISA plate," "calibrator," "controls," and various reagents used to perform a test on a biological sample.
- Performance Studies: The performance studies describe testing "samples" (serum and plasma) and comparing results to a "predicate device," which is a common characteristic of IVD submissions.
- Key Metrics: The reporting of metrics like Sensitivity and Specificity are standard for evaluating the performance of diagnostic tests.
- Predicate Device: The mention of a "predicate device" with a K number (K000535) confirms it's being compared to another legally marketed IVD.
All these elements point to the device being used to perform a test in vitro (outside the body) on human specimens to provide information for diagnosis.
N/A
Intended Use / Indications for Use
The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 IID6 of liver-kidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings.
Special conditions for the use statement(s): For prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
NBS
Device Description
The EUROIMMUN Anti-LKM-1 ELISA (IgG) consists of a microwell ELISA plate coated with LKM-1 antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Liver-kidney-microsomes (LKM-1)
Indicated Patient Age Range
Age ranged from 1 to 87 years with an average age of 50 years.
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:
- Precision/Reproducibility: Intra-assay and inter-assay reproducibility were found to be sufficient as no positive sample was found negative and vice versa (except for a single determination of a negative sample that was very close to the cutoff).
- Analytical specificity: Cross reactivity was investigated using a panel of 28 sera serologically positive for antibodies against SLA/LP. All 28 sera were negative in the Anti-LKM-1 ELISA (IgG), so no cross reactivity is expected. Interference was negligible for hemoglobin (up to 1000 mg/d), triglycerides (up to 2000 mg/dl), and bilirubin (up to 40 mg/dl).
- Comparison studies:
- Method comparison with predicate device: A study compared the EUROIMMUN Anti-LKM-1 ELISA (IgG) with an FDA released predicate device using 167 samples (58 from AIH patients, 66 from PBC patients, 15 from AIH/PBC overlap syndrome patients, and 28 from viral hepatitis patients). Additional 29 samples were created by mixing positive and negative samples, resulting in a total of 196 samples.
- Matrix comparison: The usability of plasma was investigated using 16 sample pairs of serum and corresponding plasma. Passing-Bablok regression was calculated for the comparison of serum to plasma. The 95% C.I. of the slope contained 1.0 and the 95% C.I. of the intercept contained 0, indicating equivalence of concentration between serum and the corresponding plasma matrices. Coefficients of determination were above 0.99 and %BIAS from serum was in the range of 87 to 109 %.
- Clinical studies:
- In a clinical/diagnostical study, 515 clinically characterized samples (68 from AIH-2 patients, 65 from AIH-1 patients, 15 from AIH/PBC overlap syndrome patients, and 367 from other control groups) were investigated.
- Expected values/Reference range: Levels of anti-LKM-1 antibodies (IgG) were analyzed in a panel of 150 apparently healthy blood donors. With a cut-off of ratio 1.0, only one blood donor was found positive.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Method comparison with predicate device:
- Negative agreement: 96.9% (95% C.I.: 92.9% - 99.0%)
- Positive agreement: 97.2% (95% C.I.: 85.5% - 99.9%)
- Overall agreement: 96.9% (95% C.I.: 93.5% - 98.9%)
- Clinical sensitivity for AIH type 2: 95.6% (95% C.I.: 87.6 - 99.1%)
- Clinical specificity: 100.0% (95% C.I.: 99.2 - 100.0%)
- AIH/PBC overlap syndrome: 100.0% (95% C.I.: 78.2 - 100.0%)
- Autoimmune hepatitis type 1 (AIH-1): 100.0% (95% C.I.: 94.5 - 100.0%)
- Viral hepatitis: 100.0% (95% C.I.: 96.9 - 100.0%)
- Toxic liver damages: 100.0% (95% C.I.: 76.8 - 100.0%)
- Steatohepatitis: 100.0% (95% C.I.: 85.8 - 100.0%)
- Primary biliary liver cirrhosis (PBC): 100.0% (95% C.I.: 96.7 - 100.0%)
- Primary sclerosing cholangiitis (PSC): 100.0% (95% C.I.: 82.4 - 100.0%)
- Other autoimmune diseases: 100.0% (95% C.I.: 95.5 - 100.0%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
ATTACHMENT 1
SEP 11 2012
PREMARKET NOTIFICATION 510(K) SAFETY AND EFFECTIVENESS SUMMARY (as required by 21 CFR § 807.92)
- A. 510(k)Number: K112223
- B. Purpose for Submission: New device
- C. Measurand: Anti-LKM-1 autoantibodies
- D. Type of Test: Qualitative enzyme immunoassay
- E. Applicant: EUROIMMUN US INC.
- F. Proprietary and Established Names: EUROIMMUN Anti-LKM-1 ELISA (IgG)
- G. Regulatory Information:
- Regulation: 1.
- 21 CFR 866.5660 Multiple autoantibodies immunological test system
- Classification: 2. Class II
-
- Product code:
- NBS .
- র্ব . Panel:
- Immunology
- Regulation: 1.
H. Intended Use:
-
Intended use(s): 1.
The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 IID6 of liver-kidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings. -
Indication(s) for use: 2.
- Same as intended use.
-
- Special conditions for the use statement(s): For prescription use only.
-
Special instrument requirements: বা
Microwell plate reader capable of measuring OD at 450nm for dual wavelength readings.
l. Device Description:
The EUROIMMUN Anti-LKM-1 ELISA (IgG) consists of a microwell ELISA plate coated with LKM-1 antigen, calibrator, positive and negative control, peroxidase-labelled anti-human IgG conjugate, sample buffer, wash buffer concentrate, TMB chromogen/substrate solution and stop solution.
1
Image /page/1/Picture/1 description: The image shows a repeating pattern of black and white shapes. The shapes are arranged horizontally, with a black bar at the top and bottom of the image. The white shapes in the middle are separated by black vertical bars. The white shapes are wider in the middle and narrower at the top and bottom.
Substantial Equivalence Information: J.
- Predicate device name (s): 1. Inova Quanta Lite LKM-1 ELISA
-
- Predicate 510(k) number(s): K000535
-
- Comparison with predicate:
| Similarities | ||
|---|---|---|
| Item | New Device | Predicate Device |
| Intended use | Detection of IgG antibodies to LKM-1 as an aid in | |
| diagnosis of autoimmune hepatitis. | Same | |
| Technology | ELISA | Same |
| Assay platform | 96-well microtiter plates | Same |
| Assay format | Qualitative | Same |
| Calibration | Relative | Same |
| Antigen | Recombinant cytochrome P450 IID6. | Same |
| Substrate | TMB | Same |
| Reagent preparation | All reagents, calibrator and controls are ready to | |
| use, except for the wash buffer. | Same | |
| Procedure | Sample incubation with micro-well antigen coated | |
| plate, followed by a wash step, incubation with an | ||
| anti-human IgG enzyme conjugate; wash step, | ||
| incubation with substrate; then the addition of a | ||
| stop solution and reading at 450nm. | Same | |
| Differences | ||
| Item | New Device | Predicate Device |
| Conjugate | Rabbit anti-human IgG labeled with horseradish | |
| peroxidase | Goat anti-human IgG labeled with horseradish | |
| peroxidase | ||
| Calibrators and controls | 1 calibrator | |
| 2 controls | ||
| 1 positive, 1 negative | 3 controls | |
| 1 high positive, 1 low positive, 1 negative | ||
| Wash buffer | 10x concentrate | 40x concentrate |
| Stop solution | 0.5 M sulphuric acid | 0.344 M sulphuric acid |
| Sample types and dilution | Serum or plasma | |
| 1:101 dilution | Serum | |
| 1:101 dilution | ||
| Reported results | Ratio | Units |
| Cut off level | Ratio 1.0 | 25 Units |
K. Standard/Guidance Document Referenced (if applicable):
None referenced.
L. Test Principle:
Patient samples are diluted 1:101 in sample buffer, 100 µl of each diluted patient sample and pre-diluted controls and calibrator are added to the antigen coated microtiter wells and incubated for 30 minutes at room temperature. After incubation the microtiter well strips are washed with wash buffer to remove unbound antibodies and 100 ul of the anti-human IgG enzyme conjugate reagent is added to each microtiter well. After an additional 30-minutes incubation at room temperature, the microtiter wells are again washed 3 times with 300 ul of wash buffer to remove any unbound enzyme conjugate and 100 µl of the chromogen substrate is added. The strips are incubated for 15 minutes at room temperature and 100 µl stop solution is added. The microtiter plates are placed in an ELISA reader and read at a wavelength of 450 nm and a reference wavelength of between 620 nm and 650 nm within 30 minutes.
2
Image /page/2/Picture/1 description: The image shows a repeating pattern of black shapes against a white background. The shapes are arranged horizontally and consist of a rectangular base with an oval or rounded form above it. The pattern is symmetrical and evenly spaced, creating a rhythmic visual effect.
Performance Characteristics (where applicable): M.
- Analytical performance: 1.
- a. Precision/Reproducibility:
The reproducibility of the test was investigated with samples at different points on the calibration curve. Intra-assav reproducibility is based on 20 determinations and inter-assay reproducibility on 24 determinations performed in 6 different runs (days) according to the package insert. Both intra-assay and inter-assay reproducibility were found to be sufficient as no positive sample was found negative and vice versa (except for a single determination of a negative sample that was very close to the cutoff). The following results were obtained:
Intra-assav reproducibility
| n = 20 | Anti-LKM-1 ELISA (IgG)
Ratio | | | | | |
|------------------|---------------------------------|-----------|-----------|-----------|-----------|-----------|
| | Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 |
| Mean value (x): | 0.2 | 0.8 | 1.2 | 1.9 | 3.0 | 4.7 |
| Range of values: | 0.2 – 0.2 | 0.7 - 0.8 | 1.1 – 1.3 | 1.8 – 2.0 | 2.9 – 3.2 | 4.1 – 5.0 |
| Expected result: | negative | negative | positive | positive | positive | positive |
| % positive: | 0% | 0% | 100% | 100% | 100% | 100% |
| % negative: | 100% | 100% | 0% | 0% | 0% | 0% |
Inter-assay reproducibility
| n = 24 | Anti-LKM-1 ELISA (IgG) Ratio | |||||
|---|---|---|---|---|---|---|
| Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | |
| Mean value (x): | 0.2 | 0.8 | 1.2 | 1.9 | 2.9 | 4.6 |
| Range of values: | 0.2 - 0.3 | 0.7 - 1.0 | 1.0 - 1.3 | 1.5 - 2.2 | 2.4 - 3.4 | 3.9 - 5.2 |
| Expected result: | negative | negative | positive | positive | positive | positive |
| % positive: | 0% | 4% | 100% | 100% | 100% | 100% |
| % negative: | 100% | 96% | 0% | 0% | 0% | 0% |
The Lot to Lot reproducibility was investigated during the validaton and quality control of the kit using different lots with QC samples distributed over the measurement range. Lot to lot reproducibility was found to be sufficient as no positive sample was found negative and vice versa. The following results were obtained:
| Anti-LKM-1 ELISA (IgG) | ||||||||
|---|---|---|---|---|---|---|---|---|
| Ratio | ||||||||
| Sample | Sample 1 | Sample 2 | Sample 3 | Sample 4 | Sample 5 | Sample 6 | Sample 7 | |
| n | 6 | 6 | 6 | 6 | 6 | 6 | 6 | |
| Mean value (x): | 0.9 | 1.2 | 1.7 | 2.4 | 2.9 | 4.8 | 5.8 | |
| Range of values: | 0.9 - 0.9 | 1.2 - 1.4 | 1.6 - 1.8 | 2.3 - 2.5 | 2.8 - 3.0 | 4.5 - 5.1 | 5.7 - 6.0 | |
| Expected result: | negative | positive | positive | positive | positive | positive | positive | |
| % positive: | 0% | 100% | 100% | 100% | 100% | 100% | 100% | |
| % negative: | 100% | 0% | 0% | 0% | 0% | 0% | 0% | |
| Sample | Sample 8 | Sample 9 | Sample 10 | Sample 11 | ||||
| n | 32 | 7 | 14 | 8 | ||||
| Mean value (x): | 7.3 | 8.0 | 0.1 | 0.1 | ||||
| Range of values: | 5.5 - 8.3 | 7.2 - 8.7 | 0.1 - 0.1 | 0.1 - 0.2 | ||||
| Expected result: | positive | positive | negative | negative | ||||
| % positive: | 100% | 100% | 0% | 0% | ||||
| % negative: | 0% | 0% | 100% | 100% |
Lot to lot reproducibility
3 lots x 2 runs n lots x 1 run
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 antibodies. Results are given as ratios.
3
Image /page/3/Picture/1 description: The image shows a pattern of alternating black and white vertical stripes. The black stripes are wider at the bottom and top, and narrower in the middle, creating a sort of pill shape. The white stripes are uniform in width. The pattern is repeated four times across the image.
-
ರ. Detection limit:
Not applicable. -
Analytical specificity: ର.
Cross-reactivity: Cross reactivity was investigated using a panel of 28 sera serologically positive for antibodies against SLA/LP. All 28 sera were negative in the Anti-LKM-1 ELISA (IgG), so no cross reactivity is expected.
Interference: To investigate the influence from hemoglobin, triglycerides and bilirubin, 5 different specimens at different anti-LKM-1 concentrations (ratio 1.1 - 9.3) were spiked with potential interfering substances and were incubated with the test system. The recovery in relation to the unspiked sample without interferent was calculated. The individual recovery was within the range of 86 - 126%. No significant interference was observed for concentrations of up to 1000 mg/d for hemoglobin, 2000 mg/dl for triglyceride and 40 mg/dl for bilirubin.
- f. Assay cut-off:
- Ratio 1.0
2. Comparison studies:
- Method comparison with predicate device: a.
A study was performed in cooperation with a university clinical hospital comparing the performance of the EUROIMMUN Anti-LKM-1 ELISA (IgG) and an FDA released predicate device. 167 samples were investigated (58 from AIH patients, 66 from PBC patients, 15 from patients with AIH/PBC overlap syndrome and 28 from patients with viral hepatitis). The panel consisted of 30 men and 137 women. Age ranged from 1 to 87 years with an average age of 50 years. To cover the lower range with more samples, additional 29 samples were created by mixing of positive and negative samples.
| n = 196 | Predicate ELISA | ||||
|---|---|---|---|---|---|
| positive | borderline | negative | |||
| EUROIMMUN | |||||
| Anti-SLA/LP ELISA (IgG) | positive | 35 | 0 | 5 | |
| negative | 1 | 0 | 155 | ||
| Negative agreement | 155 / 160 = | 96.9% | 95% C.I.: | 92.9% - 99.0% | |
| Positive agreement | 35 / 36 = | 97.2% | 95% C.I.: | 85.5% - 99.9% | |
| Overall agreement | 190 / 196 = | 96.9% | 95% C.I.: | 93.5% - 98.9% |
- Matrix comparison: b.
The usability of plasma was investigated using 16 sample pairs each of serum and corresponding plasma. The samples cover concentrations in the diagnostically important range and the cut-off. Passing-Bablok regression was calculated for the comparison of serum to plasma. The results are shown in the table below.
| EDTA plasma | Heparin plasma | Citrate plasma | |
|---|---|---|---|
| Regression equation | |||
| (y = plasma, x = serum) | $y = 0.02 + 1.00 x$ | $y = -0.00 + 1.00 x$ | $y = 0.00 + 0.97$ |
| 95% C.I. of intercept | -0.04 to 0.06 | -0.03 to 0.06 | -0.06 to 0.05 |
| 95% C.I. of slope | 0.98 to 1.02 | 0.97 to 1.01 | 0.95 to 1.00 |
A comparison in which the 95% C.I. of the slope contains 1.0 and the 95% C.I. of the intercept contains 0 indicates equivalence of concentration between serum and the corresponding plasma matrices. The comparison above satisfies this condition.
Coefficients of determination were found to be above 0.99 and %BIAS from serum was in the range of 87 to 109 % (serum = 100 %).
4
Image /page/4/Picture/1 description: The image shows a repeating pattern of black shapes against a white background. The shapes are arranged horizontally and consist of a thick black line at the top and bottom, with a series of rounded, pillar-like black figures in between. The black figures are evenly spaced and have a slightly concave shape on either side, creating a symmetrical design.
3. Clinical studies:
In a clinical/diagnostical study, performed in cooperation with several university, hospital and private laboratories, in total 515 clinically characterized samples (68 from AIH-2 patients, 65 from AIH-1 patients, 15 from patients with AIH/PBC overlap syndrome and 367 from other control groups) were investigated for anti-UKM-1 antibodies (IgG). The EUROIMMUN Anti-LKM-1 ELISA (IgG) showed a sensitivity for AlH type 2 of 95.6% (95% C.I.: 87.6 - 99.1%). The specificity was 100.0% (95% C.I.: 99.2 - 100.0%).
- Clinical sensitivity: a.
| No. | Panel | n | Anti-LKM-1 ELISA (IgG) | ||
|---|---|---|---|---|---|
| positive | % | 95% C.I. | |||
| 1 | Autoimmune hepatitis type 2 (AIH-2) | 68 | 65 | 95.6% | 87.6 – 99.1% |
- b. Clinical specificity:
| No. | Panel | n | negative | % | 95% C.I. |
|---|---|---|---|---|---|
| 2 | AIH/PBC overlap syndrome | 15 | 15 | 100.0% | 78.2 - 100.0% |
| 3 | Autoimmune hepatitis type 1 (AIH-1) | 65 | 65 | 100.0% | 94.5 - 100.0% |
| 4 | Viral hepatitis | 118 | 118 | 100.0% | 96.9 - 100.0% |
| 5 | Toxic liver damages | 14 | 14 | 100.0% | 76.8 - 100.0% |
| 6 | Steatohepatitis | 24 | 24 | 100.0% | 85.8 - 100.0% |
| 7 | Primary biliary liver cirrhosis (PBC) | 111 | 111 | 100.0% | 96.7 - 100.0% |
| 8 | Primary sclerosing cholangiitis (PSC) | 19 | 19 | 100.0% | 82.4 - 100.0% |
| 9 | Other autoimmune diseases* | 81 | 81 | 100.0% | 95.5 - 100.0% |
| Total | 447 | 447 | 100.0% | 99.2 - 100.0% |
*from the following groups: MCTD (n = 20), celiac disease (n = 11), Diabetes Type I (n = 12), Hashimoto (n = 11), Grave's disease (n = 12), ulcerative colitis (n = 15)
- Other clinical supportive data (when a. and b. are not applicable): C. Not applicable.
Not applicable
Clinical cut-off:
Clinical cut-off:
See Assay cut-off.
-
- Expected values/Reference range:
The levels of anti-LKM-1 antibodies (IgG) were analyzed with the EUROIMMUN Anti-LKM-1 ELISA (IgG) in a panel of 150 apparently healthy blood donors (mixed age and sex). With a cut-off of ratio 1.0, only one blood donor was found positive.
- Expected values/Reference range:
| Positives | 1 |
|---|---|
| Negatives | 149 |
| Lowest value | Ratio 0.0 |
| Highest value | Ratio 3.4 |
| Mean value | Ratio 0.2 |
| Std dev. (SD) | Ratio 2.29 |
| 95th percentile | 0.4 |
| 99th percentile | 0.8 |
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
o. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
Date
Signature
Kathryn Kohl, Managing Director Typed Name, Title
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of an eagle or other bird, with its wings spread.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 1 1 2012
EUROIMMUN US Inc. c/o Ms. Kathryn Kohl Managing Director 1100 The American Road Morris Plains, NJ 07950
Re: K112223
Trade/Device Name: EUROIMMUN Anti-LKM-1 (IgG) Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: NBS Dated: September 5, 2012 Received: September 7, 2012
Dear Ms. Kohl:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
6
Page 2 – Ms. Kathryn Kohl
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ﮯ ﮨﯿﮟ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍﺱ ﮐﮯ ﺍ
Reena Philip
Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known): K112223
Anti-LKM-1 ELISA (IgG) Device Name:
Indications For Use:
The EUROIMMUN Anti-LKM-1 ELISA (IgG) test kit is intended for the qualitative detection of IgG class autoantibodies against LKM-1 (cytochrome P450 IID6 of liverkidney-microsomes) in human serum and plasma. It is used as an aid in the diagnosis of autoimmune hepatitis, type 2, in conjunction with other laboratory and clinical findings.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K112223
Page 1 of