(68 days)
Not Found
No
The description details a standard enzyme immunoassay based on chemical reactions and spectrophotometric measurement. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making.
No
The device is an enzyme immunoassay intended for the qualitative and semiquantitative determination of 6-Acetylmorphine, a drug metabolite, in human urine. It is a diagnostic tool and does not treat or alleviate a disease, injury, or disability.
Yes
The "6-Acetylmorphine Enzyme Immunoassay" is intended for the qualitative and semiquantitative determination of 6-Acetylmorphine in human urine, which is a diagnostic purpose. While it provides a "preliminary analytical result" and requires confirmation, its primary intended use is to determine the presence and quantity of a substance in a biological sample for clinical assessment.
No
The device description clearly outlines a homogeneous enzyme immunoassay with ready-to-use liquid reagents and relies on spectrophotometric measurement at 340 nm, indicating a hardware-based chemical analysis system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the "qualitative and semiquantitative determination of 6-Acetylmorphine in human urine." This is a diagnostic test performed on a biological sample (urine) in vitro (outside the body).
- Device Description: The description details a "homogeneous enzyme immunoassay" which is a laboratory technique used to measure substances in biological samples.
- Anatomical Site: The sample is "human urine," a biological specimen.
- Performance Studies: The document includes performance data like precision, limit of detection, linearity, and method comparison using "clinical samples," which are typical for IVD devices.
- Predicate Device: The mention of a "Predicate Device" with a K number (K001178) indicates that this device is being compared to a previously cleared IVD device, a common practice in the regulatory pathway for IVDs.
All of these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LZI 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of 6-Acetylmorphine in human urine, at a cutoff value of 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The LZI 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI 6-Acetylmorphine Enzyme Immunoassay.
The 6-Acetylmorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI 6-AcetyImorphine Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
The LZI 6-Acetylmorphine assay is a homogeneous enzyme immunoassay with ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (GoPDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the absence of drug in the sample, 6-Acetymorphine-labeled G6PDH activity. In the absence of the sample, 6-Acetymorphine-labeled G6PDH activity of the included conjugate is bound to antibody, and the enzyme activity would bind to free drug, the unbound 6-Acetylmorphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
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
Professional use with automated clinical chemistry analyzers.
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)
Precision:
Semi-Quantitative, ng/mL: N=88, various concentrations from 0 ng/mL to 20 ng/mL tested, showing within-run and total precision (Mean, SD, %CV). For 10 ng/mL, within-run precision was 9.7 (mean), 0.34 (SD), 3.5 (%CV) and total precision was 9.7 (mean), 0.4 (SD), 4.4 (%CV).
Semi-Quantitative Positive/Negative Results: 10 ng/mL Cutoff, N=88. For 10 ng/mL, 6 Pos/16 Neg within run, and 22 Pos/66 Neg total.
Qualitative, mA/min: N=88, various concentrations from 0 ng/mL to 20 ng/mL tested, showing within-run and total precision (Mean, SD, %CV). For 10 ng/mL, within-run precision was 437.4 (mean), 2.2 (SD), 0.5 (%CV) and total precision was 437.4 (mean), 2.6 (SD), 0.6 (%CV).
Qualitative Positive/Negative Results: 10 ng/mL Cutoff, N=88. For 10 ng/mL, 10 Pos/12 Neg within run, and 41 Pos/47 Neg total.
Limit of Detection: The lowest concentration that can be differentiated from negative urine with 95% confidence is 2 ng/mL.
Linearity: Regression equation y = 0.9961x - 0.0961, correlation r = 0.999.
Method Comparison: Clinical Samples: From a total of eighty (80) clinical unaltered samples, 10 ng/mL Cutoff showed 100 % agreement with positive samples and 93 % agreement with negative samples.
Endogenous Compound Interference and Specificity - Cross sections: No significant undesired cross reactivity observed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Limit of Detection: 2 ng/mL (95% confidence)
Method Comparison (clinical unaltered samples, 10 ng/mL cutoff): 100% agreement with positive, 93% agreement with negative.
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Lin-Zhi International, Inc.
JUL - 6 2010
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted
ian and the submitted by the supports of SMDA 1990 and 21 CFR 807.92. is summary of 510(k) safety and effectiveness algoring and 21 CFR 807.92.
in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Introduction
According to the requirements of 21 CFR 807.92, the following information of substantial equivalence. According to the requirements of 21 CPK 807.92, the 101.92, the formaliance.
sufficient detail to understand the basis for a determination of substantial equivalence.
In and
Submitter name, Address, and Contact
Lin-Zhi International, Inc. 670 Almanor Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 (408) 732-3849 Fax: e-mail: bclin@lin-zhi.com
Bernice Lin, Ph.D. Contact: V.P. of Operations
Device Name and Classification
Classification Name:
Enzyme Immunoassay, Opiates Class II, DJG (91 Toxicology), 21 CFR 862.3650
6-Acetylmorphine Calibrators, Class II, DLJ (91 Toxicology), 21 CFR 862.3200
6-AcetyImorphine Controls, Classification LAS (91 Toxicology), 21 CFR 862.3280
Common Name: Proprietary Name: Homogeneous 6-Acetylmorphine Enzyme Immunoassay LZI 6-Acetylmorphine Enzyme Immunoassay, LZI 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators
LZI 6-Acetylmorphine Drugs of Abuse (DAU) Controls LZI 6-AcetyImorphine Drugs of Abuse (DAU) Controls
1
Legally Marketed Predicate Device(s)
The LZI 6-Acetylmorphine Enzyme Immunoassay (EIA) is substantially equivalent to the The LZI 6-Acetylmorphine Eizzyne Immunosasay (EIF) is Subsminary and Controls for Microgenics CEDIA® DAU 6-Asetylmorphine Assay, Canbiaeor - Corp. The LZI 6-Hitachi 717 Systems (K001178) manufactured or similar to its predicate in terms of
Acetylmorphine Enzyments in Jacksonersponents and clinical performance. Acetylmorphine Enzyme Immunoassay Is Identical of Minister Components, and clinical performance.
Device Description
The LZI 6-Acetylmorphine assay is a homogeneous enzyme immunoassay with ready-toresult of the same the same in becal on competition between drug in the sample and The LZI 6-Acetylmorphine assay is based on competition between drug in the sample and
use liquid reagent. The assay is based on competition between drug for a fixed use liquid reagent. The enzyme glucose-b-phosphate dehydrogenase (GoPDH) for a fixed
drug labeled with the enzyme glucose-cryphosphate dehydrogenase (GoPDH) for the drug labeled with the enzyme glucose-o-phosphate decreases upon binding to the amount of antibody in the reagent. Enzyne activity deceases ipper and of earste of earses of earspress antibody, and the absence of drug in the sample, 6-Acetymorphine-labeled G6PDH
activity. In the absence of drug in the sample, 6-Acetymorphine-labeled G6PDH activity. I In the absence of the Saliple, of the included conjugate is bound to antibody, and the entivaly would bind to free drug, the unbound 6when free drug is present in the sample, and both enroyment of enver activity. Active
Active Acety In the CoPDH then exhibits its maximal enzyme activity, Act Acetylmorphine-labeled G6PDH then exchibits ins may be constitution of the may be of the may be and enzyme converts nicotinamide adeline united spectrophotometrically at 340 nm.
absorbance change that can be measured spectrophotometrically at 340 nm.
Intended Use
The LZI 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and The LZI 6-Acetylmorphine Enzyme Immunications in human urine, at a cutoff value of
semi-quantitative determination of 6-Acetylmorphine in human urine, at a cutoff value of semi-quantitative determination of 6-Acetyimorphine in human annot in the first and the all the chemistry analyzers.
The LZI 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators The LZI 6-Acetylmorphine Drugs of Abuse (DAO) Canolation as 17-1
in the qualitative and semi-quantitative calibration of the LZI 6-Acetylmorphine Enzyme Immunoassay.
The 6-Acetylmorphine Drugs of Abuse (DAU) Controls are for use as assayed quality The 6-Acetylmorphine Drugs of Abuse (DAO) Colubis are for use and the limited in the Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative The assay provides only a preliminary and to obtain a confirmed analytical result. Gas or
chemical method must be used in order to obtain a confirmed andytical result. Gas or chemical method must be used in order to overnment (GCMS) is the preferred
liquid chromatography/mass spectrometry (GCMS) is the prefered liquid chromatography/mass spectromers) (OC/AS of ciornized subscription be
confirmatory method). Clinical consideration and professional judgment should be confirmatory method). Clinical consideration und professional July 2018
exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
2
Performance Characteristics Summary:
Characteristics Summary: 1
1 Summary: Andrer I el 101 Analyzer
Precision:
Precision:
Precision: Semi-Quantitative, ng/mL
| N=88
| (ng/mL) | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| Mean | SD | % CV | Mean | SD | % CV | |
| 0 ng/mL | 0.2 | 0.19 | N/A | 0.2 | 0.3 | 169.4 |
| 2.5 ng/mL | 2.8 | 0.32 | 11.6 | 2.8 | 0.3 | 12.6 |
| 5.0 ng/mL | 5.1 | 0.28 | 5.5 | 5.1 | 0.4 | 7.2 |
| 7.5 ng/mL | 7.4 | 0.37 | 5.0 | 7.4 | 0.4 | 5.1 |
| 10 ng/mL | 9.7 | 0.34 | 3.5 | 9.7 | 0.4 | 4.4 |
| 12.5 ng/mL | 12.2 | 0.4 | 3.1 | 12.2 | 0.4 | 3.6 |
| 15 ng/mL | 14.6 | 0.47 | 3.3 | 14.6 | 0.5 | 3.7 |
| 17.5 ng/mL | 17.7 | 0.44 | 2.5 | 17.7 | 0.5 | 2.9 |
| 20 ng/mL | 19.9 | 0.51 | 2.6 | 19.9 | 0.6 | 2.9 |
Semi-Quantitative Positive/Negative Results:
| 10 ng/mL Cutoff Result: | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| Sample | |||||
| Concentration | % of Cutoff | Number of | |||
| Determination | Immunoassay | ||||
| Result | Number of | ||||
| Determination | Immunoassay | ||||
| Result | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 5.0 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 7.5 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Positive |
| 10 ng/mL | 100.0% | 22 | 6 Pos/16 Neg | 88 | 22 Pos/66 Neg |
| 12.5 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 15 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 17.5 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 20 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
Precision: Qualitative, mA/min
| N=88
| (mA/min) | Within Run | Total Precision | ||||
|---|---|---|---|---|---|---|
| Mean | SD | % CV | Mean | SD | % CV | |
| 0 ng/mL | 358.6 | 2.2 | 0.6 | 358.6 | 2.4 | 0.7 |
| 2.5 ng/mL | 380.0 | 2.5 | 0.7 | 380.0 | 2.8 | 0.7 |
| 5.0 ng/mL | 399.4 | 2.2 | 0.6 | 399.4 | 2.4 | 0.6 |
| 7.5 ng/mL | 419.5 | 2.4 | 0.6 | 419.5 | 2.7 | 0.6 |
| 10 ng/mL | 437.4 | 2.2 | 0.5 | 437.4 | 2.6 | 0.6 |
| 12.5 ng/mL | 454.8 | 2.0 | 0.4 | 454.8 | 3.0 | 0.7 |
| 15 ng/mL | 470.4 | 3.8 | 0.8 | 470.4 | 4.6 | 1.0 |
| 17.5 ng/mL | 489.2 | 2.3 | 0.5 | 489.2 | 3.0 | 0.6 |
| 20 ng/mL | 500.1 | 2.2 | 0.4 | 500.1 | 2.8 | 0.6 |
3
| Qualitative Positive/Negative | Within Run | Total Precision | |||
|---|---|---|---|---|---|
| 10 ng/mL Cutoff Result: | % of Cutoff | Number of Determination | Immunoassay Result | Number of Determination | Immunoassay Result |
| Sample | |||||
| Concentration | |||||
| 0 ng/mL | -100.0% | 22 | 22 Negative | 88 | 88 Negative |
| 2.5 ng/mL | -75.0% | 22 | 22 Negative | 88 | 88 Negative |
| 5.0 ng/mL | -50.0% | 22 | 22 Negative | 88 | 88 Negative |
| 7.5 ng/mL | -25.0% | 22 | 22 Negative | 88 | 88 Positive |
| 10 ng/mL | 100.0% | 22 | 10 Pos/12 Neg | 88 | 41 Pos/47 Neg |
| 12.5 ng/mL | +25.0% | 22 | 22 Positive | 88 | 88 Positive |
| 15 ng/mL | +50.0% | 22 | 22 Positive | 88 | 88 Positive |
| 17.5 ng/mL | +75.0% | 22 | 22 Positive | 88 | 88 Positive |
| 20 ng/mL | +100.0% | 22 | 22 Positive | 88 | 88 Positive |
litative Positive/Negative Results:
Limit of Detection:
The lowest concentration that can be differentiated from the negative urine with 95%
http://www.balassurined.as 2 ng/mL. The Towest Concontrailer
confidence is determined as 2 ng/mL.
Linearity:
Linearity :
When comparing the result (y) and target (x) value, using the least squares regression
When comparing association anyation and correlation are as follow: I haben in the regression equation and correlation are as follow:
technique, the regression equation and correlation are as follow:
technique, and 1948-1948 - 3-10 0961 technique, the regressions = = 0.9961
Method Comparison: Clinical Samples
Method Comparison: (90) clinical unaltered sam
Method Comparison: Chinear Back Promotives:
From a total of eighty (80) clinical unaltered samples:
From a total of eighty (80) clinical unaltered samples:
10 ng/mL Cutoff
(100 % agreement with positive, 93 % agreement with negative samples)
(100% agreements of the may be Endogenous Compound Interference and Specificity - Cross sections of your - substance - of
No significant undestiners for list of compounds tested. No significant undesired cross Teactals - Eross - February
observed. See product insert for list of compounds tested.
Summary:
Summation provided in this pre-market notification demonstrates that the LZI 6-The information provided in this pre-market notification and and and the marketed
Acetylmorphine Enzyme Immunoassay is substantially equivalent was ally marketed by The information browned in and say is substantially equivalence was demonstrated
Acetymorphine for its general intended use. Substantials on the comments predicate device for its general intended use and physical properties to the scennercially
through comparison of intended use and physical properties on the somencedally through comparison of intented by liquid chromatographylines spectrometry
available predicate device as confimed by liquid chromation spectrometry
available predicate device through comparison or medical medod. The information supplied in this pre-market
available predicate device as confimed medion upplied in this pre-market
(LC/MS), an (LC/MS), an independent analytical method. The information supplied in the provinces of the provinces
notification provides reasonable assurance that the LZI 6-Acetylmorphin (2001) provides reasonable "assurable" that "that "has and "his stated intended use.
Immunoassay is safe and effective for its stated intended use.
4
Image /page/4/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Lin-Zhi International, Inc. c/o Berince Lin, Ph.D. V.P. of Operations 670 Almanor Ave Sunnyvale, CA 94085
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K101195
Trade/Device Name: 6-Acetylmorphine Enzyme Immunoassay and 6-Acetylmorphine Calibrators and Controls
Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ and LAS Dated: April 28, 2010 Received: April 29, 2010
JUL 0 6 2010
Dear Dr. Lin:
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 either class II (Special Controls) or class III (PMA), 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 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).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K101195
Device Name: 6-Acetylmorphine Enzyme Immunoassay 6-Acetylmorphine Calibrators and Controls
Indications for Use:
The 6-Acetylmorphine Enzyme Immunoassay is intended for the qualitative and semiquantitative determination of 6-Acetylmorphine in human urine, at a cutoff value of 10 ng/mL. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The 6-Acetylmorphine Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the 6-Acetylmorphine Enzyme Immunoassay.
The 6-Acetylmorphine Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the 6-AcetyImorphine Enzyme Immunoassay.
The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The Counter Use (21 CFR 807 Subpart C)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C. D. A.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K101195