(34 days)
Not Found
No
The description details a standard enzyme immunoassay kit and its components, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in-vitro diagnostic device used for the qualitative and semi-quantitative analysis of Buprenorphine in human urine. It is not intended to treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in-vitro diagnostic device is for prescription use only."
No
The device is an in-vitro diagnostic device consisting of chemical reagents (antibody/substrate reagent, enzyme conjugate reagent, calibrators, and controls) used in a laboratory setting with automated clinical chemistry analyzers. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "This in-vitro diagnostic device is for prescription use only."
Furthermore, the device is designed to analyze human urine samples to detect the presence of Buprenorphine, which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Immunalysis Buprenorphine Urine Enzyme Immunoassay:
The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Buprenorphine Urine Controls:
The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay.
Immunalysis Buprenorphine Urine Calibrators:
The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes rabbit antibodies to Buprenorphine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes buprenorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The buprenorphine calibrator and controls consists of a single calibrator at 5ng/mL, a control set containing a LOW control at 3.75ng/mL and a HIGH control at 6.25ng/mL and a calibrator set containing a negative calibrator, a Level 1 calibrator at 5ng/mL, a Level 2 calibrator at 10ng/mL, a Level 3 calibrator at 20ng/mL and a Level 4 calibrator at 40ng/mL.
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
laboratories
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/ Cutoff Characterization Study: performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75% and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. In addition, it also verified the product performance relative to the ability of the device to produce the same value during repeated measurements. The instrument used for this test was a Beckman Coulter AU 400e.
- Qualitative Analysis: At 5 ng/mL cutoff, 48 Negative/32 Positive results out of 80 determinations.
- Semi-Quantitative Analysis: At 5 ng/mL cutoff, 33 Negative/ 47 Positive results out of 80 determinations.
- Specificity and Cross-Reactivity Study: Structurally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoff. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. The instrument used for this test was a Beckman Coulter AU 400e.
- Cross-reactivity: Buprenorphine (100.00%), NorBuprenorphine (90.91%), Buprenorphine Glucuronide (0.17%), NorBuprenorphine Glucuronide (0.13%). Many other tested compounds showed no cross-reactivity (N.D.).
- Interference Study: Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. The instrument used for this test was a Beckman Coulter AU 400e.
- Results: Boric Acid and Riboflavin caused a false negative response at the concentrations tested. All other potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition.
- Linearity/ Recovery Study: A drug free urine pool was spiked with a high concentration of the target analyte as a high value specimen. Additional pools were made by serially diluting the high value specimen. The study verified assay linearity in the semi-quantitative mode. The instrument used for this test was a Beckman Coulter AU 400e.
- Recovery: Ranged from 77% to 105% for expected concentrations from 5 ng/mL to 55 ng/mL.
- Method Comparison Study: Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. The study verified that the product performance can be verified by Mass Spectrometry. The instrument used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry.
- Qualitative Assay Performance: 100% agreement for positive and negative results across concentration ranges (7.5 ng/mL).
- Semi-Quantitative Assay Performance: 100% agreement for positive and negative results across concentration ranges (7.5 ng/mL).
- Stability Study:
- Closed accelerated stability study: Supported an initial expiration date of 1 year for reagents and 12 months for calibrators and controls. Instrument used: Beckman Coulter AU 400e. Real time stability studies are ongoing.
- Open/ on-board stability study: Supported an initial open vial expiration date of 28 days for reagents when stored on board the instrument at 2°C to 8°C. Instrument used: Beckman Coulter AU 400e.
- Calibrator and Control Stability: An open accelerated stability study was performed at 37°C to establish the initial open vial expiration dating. Supported an initial open vial expiration date of 6 months. Instrument used: Beckman Coulter AU 400e. Real time stability studies are ongoing.
- Calibrator and Control Traceability: All components traced to a commercially available standard solution from Cerilliant Chemicals.
- Calibrator and Control Value Assignment: Calibrators and controls are manufactured and tested by mass spectrometry. Values assigned once Mass spectrometry results are within acceptable ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
510(k) SUMMARY
JUL 0 1 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
- A. Contact Information
| 1. | Manufacturer: | Immunalysis Corporation |
|---|---|---|
| 2. | Contact Name: | Joseph Ginete |
| 3. | Contact Title: | Regulatory Affairs Specialist |
| 4. | Address: | 829 Towne Center Drive Pomona, CA 91767 |
| 5. | Phone: | (909) 482-0840 |
| 6. | Fax: | (909) 482-0850 |
| 7. | Email: | jginete@immunalysis.com |
| 8. | Summary prepared on: | June 30, 2014 |
| B. Device Information | ||
| 1. Trade Name: | Immunalysis Buprenorphine Urine Enzyme Immunoassay | |
| Immunalysis Buprenorphine Urine Controls | ||
| Immunalysis Buprenorphine Urine Calibrators | ||
| 2. Common Name: | Immunalysis Buprenorphine Urine Enzyme Immunoassay | |
| Immunalysis Buprenorphine Urine Controls | ||
| Immunalysis Buprenorphine Urine Calibrators | ||
| 3. Device Classification: | II | |
| 4. | Regulation Number: | CFR 862.3650 Opiate Test System |
| CFR 862.3200 Clinical Toxicology Calibrator | ||
| CFR 862.3280 Clinical Toxicology Control Materials | ||
| 5. Panel: | Toxicology(91) | |
| 6. | Product Code: | DJG |
| DLJ | ||
| LAS | ||
| C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) | ||
| 1. | Predicate Device: | CEDIA Buprenorphine Assay |
| 1. | Predicate Device: | CEDIA Buprenorphine Assay
CEDIA Buprenorphine Controls
CEDIA Buprenorphine Calibrators |
|----|---------------------|----------------------------------------------------------------------------------------------|
| 2. | Predicate Company: | Microgenics |
| 3. | Predicate K Number: | K040316 |
1
1
D. Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes rabbit antibodies to Buprenorphine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes buprenorphine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The buprenorphine calibrator and controls consists of a single calibrator at 5ng/mL, a control set containing a LOW control at 3.75ng/mL and a HIGH control at 6.25ng/mL and a calibrator set containing a negative calibrator, a Level 1 calibrator at 5ng/mL, a Level 2 calibrator at 10ng/mL, a Level 3 calibrator at 20ng/mL and a Level 4 calibrator at 40ng/mL.
E. Intended Use
Immunalysis Buprenorphine Urine Enzyme Immunoassay:
The Immunalysis Buprenorphine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 5ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Buprenorphine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Buprenorphine. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Buprenorphine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectroscopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Buprenorphine Urine Controls:
The Immunalysis Buprenorphine Urine Controls are used as control materials in the Immunalysis Buprenorphine Urine Enzyme Immunoassay.
Immunalysis Buprenorphine Urine Calibrators:
The Immunalysis Buprenorphine Urine Calibrators are used as calibrators in the Immunalysis Buprenorphine Urine Enzyme Immunoassay for the qualitative and semiquantitative determination of Buprenorphine in urine on automated clinical chemistry analyzers.
2
Comparison of the new device with the predicate device F
| Item | Predicate Device (K040316) | Test Device |
|---|---|---|
| Intended Use | For the qualitative and semi- | |
| quantitative determination of the | ||
| presence of buprenorphine in human | ||
| urine at a cutoff of 5 ng/ml | For the qualitative and semi- | |
| quantitative determination of the | ||
| presence of buprenorphine in human | ||
| urine at a cutoff of 5 ng/ml | ||
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Buprenorphine | Buprenorphine |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 5ng/mL of Buprenorphine | 5ng/mL of Buprenorphine |
| Test System | Homogenous Enzyme Immunoassay | Homogenous Enzyme Immunoassay |
| Materials | Buffer 1, Buffer 2, Lyophilized Reagent | |
| la and Lyophilized Reagent | Antibody/ Substrate Reagents and | |
| Enzyme Labeled Conjugate | ||
| Mass Spectroscopy | ||
| Confirmation | Required for preliminary positive | |
| analytical results | Required for preliminary positive | |
| analytical results | ||
| Antibody | Mouse monoclonal anti-buprenorphine | |
| derivative | Rabbit Monoclonal Antibody to | |
| Buprenorphine | ||
| Storage | 2 - 8°C until expiration date | 2 - 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | One (1) Level (5ng/mL) | One (1) Level (5ng/mL) |
| Control Set Levels | Two (2) Levels (3ng/mL and 7ng/mL) | Two (2) Levels (3.75ng/mL and |
| 6.25ng/mL) | ||
| Calibrator Set | ||
| Levels | Five (5) Levels (0, 5, 20, 50 and 75 | |
| ng/mL) | Five (5) Levels (0, 5, 10, 20 and 40 | |
| ng/mL) |
G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Buprenorphine Urine Enzyme Immunoassay to the predicate
-
- Precision/ Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75% and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. In addition, it also verified the product performance relative to the ability of the device to produce the same value during repeated measurements. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The following is a summary table of the Qualitative Analysis for the 5ng/mL cutoff test data results.
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 1.25 | -75% | 80 | 80 Negative |
| 2.5 | -50% | 80 | 80 Negative |
| 3.75 | -25% | 80 | 80 Negative |
| 5 | Cutoff | 80 | 48 Negative/32 Positive |
| 6.25 | +25% | 80 | 80 Positive |
| 7.5 | +50% | 80 | 80 Positive |
| 8.75 | +75% | 80 | 80 Positive |
| 10 | +100% | 80 | 80 Positive |
3
- b. The follówing is a summary table of the Semi-Quantitative Analysis for the 5ng/mL cutoff test data results.
| Semi-Quantitative Analysis (for 5ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 1.25 | -75% | 80 | 80 Negative |
| 2.5 | -50% | 80 | 80 Negative |
| 3.75 | -25% | 80 | 80 Negative |
| 5 | Cutoff | 80 | 33 Negative/ 47 Positive |
| 6.25 | +25% | 80 | 80 Positive |
| 7.5 | +50% | 80 | 80 Positive |
| 8.75 | +75% | 80 | 80 Positive |
| 10 | +100% | 80 | 80 Positive |
- Specificity and Cross-Reactivity - Structurally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoff. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. The instrument used for this test was a Beckman Coulter AU 400e.
| Structurally Related Compounds - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Buprenorphine | 5 | N/A | 100.00 |
| NorBuprenorphine | 5.5 | POS | 90.91 |
| Buprenorphine Glucuronide | 3,000 | POS | 0.17 |
| NorBuprenorphine Glucuronide | 4,000 | POS | 0.13 |
| 6-Acetyl morphine | 100,000 | NEG | N.D. |
| Codeine | 100,000 | NEG | N.D. |
| Dihydrocodeine | 100,000 | NEG | N.D. |
| EDDP | 100000 | NEG | N.D. |
| EMDP | 100,000 | NEG | N.D. |
| Ethyl Morphine | 100,000 | NEG | N.D. |
| Heroin | 100,000 | NEG | N.D. |
| Hydrocodone | 100,000 | NEG | N.D. |
| Hydromorphone | 100,000 | NEG | N.D. |
| LAAM | 100,000 | NEG | N.D. |
| Levorphanol | 100,000 | NEG | N.D. |
| Methadone | 100,000 | NEG | N.D. |
| Meperidine | 100,000 | NEG | N.D. |
| Morphine 3 Glucuronide | 100,000 | NEG | N.D. |
| Morphine 6 Glucuronide | 100,000 | NEG | N.D. |
| Morphine | 100,000 | NEG | N.D. |
| Nalorphine | 100,000 | NEG | N.D. |
| Naloxone | 100,000 | NEG | N.D. |
| Naltrexone | 100,000 | NEG | N.D. |
| Norpropoxyphene | 100,000 | NEG | N.D. |
| Oxycodone | 100,000 | NEG | N.D. |
| Oxymorphone | 100,000 | NEG | N.D. |
| Diacetyl Morphine | 100,000 | NEG | N.D. |
- a. The qualitative result summary table is outlined below:
N.D. = Not Detected (7.5 ng/mL | Agreement (%) |
|-----------------------|-----------|---------------|-------------|------------|---------------|
| Qualitative/ Positive | 0 | 0 | 4 | 36 | 100% |
| Qualitative/ Negative | 36 | 4 | 0 | 0 | 100% |
9
- c. The following is a comparison table of semi-quantitative assay performance for the 5ng/mL cutoff
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test Device | (+) | 40 | 0 |
| (-) | 0 | 40 |
- d. The following is a summary table of semi-quantitative assay performance for the 5nq/mL cutoff
| Assay Performance verified by LC/MS - 5ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Buprenorphine Concentration | Agreement (%) | |||
| 7.5 ng/mL | |||||
| Semi-Quantitative/ Positive | 0 | 0 | 4 | 36 | 100% |
| Semi-Quantitative / Negative | 36 | 4 | 0 | 0 | 100% |
- Stability -
a. A closed accelerated stability study was performed on reagents, calibrators and controls at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year for reagents. This stability study supported an initial expiration date of 12 months for calibrators and controls. The instrument used for this test was a Beckman Coulter AU 400e.
-
- The following is a summary of the qualitative stability data. The 0 and 3.75ng/mL levels were negative in comparison to the 5ng/mL cutoff for Day 0. 2. 8. 16. 24. 32 and 40. The 6.25ng/mL level was positive in comparison to the 5ng/mL cutoff for Day 0, 2, 8, 16, 24, 32 and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
-
- The following is a summary of the semi-quantitative stabilility data for the 5ng/mL cutoff. The 3.75ng/mL level was negative in comparison to the 5ng/mL cutoff for Day 0, 2, 8, 16, 24, 32 and 40. The 6.25ng/mL level was positive in comparison to the 5ng/mL cutoff for Day 0, 2, 8, 16, 24, 32 and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- b. An open/ on-board stability study was performed on reagents to establish expiration dating when reagents are opened and stored on board the instrument at 2°C to 8°C. The stability study supported an initial open vial expiration date of 28 days. The instrument used for this test was a Beckman Coulter AU 400e.
-
- The following is a summary of the qualitative open/ on-board stability data for the 5ng/mL cutoff. All replicates for the 3.75ng/mL level were negative in comparison to the 5ng/mL cutoff for Day 0, 7, 14, 21 and 28. All replicates of the 6.25ng/mL level were positive in comparison to the 5ng/mL cutoff for Day 0, 7, 14, 21 and 28.
-
- The following is a summary of the semi-quantitative open/ onboard stability data for the 5ng/mL cutoff. The mean of the replicates for the 3.75ng/mL level were negative in comparison to the 5ng/mL cutoff for Day 0, 7, 14, 21 and 28. The mean of the replicates of the 6.25ng/mL level were positive in comparison to the 5ng/mL cutoff for Day 0, 7, 14, 21 and 28.
-
-
- Calibrator and Control Traceability - all components of the calibrator and controls have been traced to a commercially available standard solution from Cerilliant Chemicals.
10
-
- Calibrator and Control Stability An open accelerated stability study was performed at 37°C to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 6 months. The instrument used for this test was a Beckman Coulter AU 400e. All calibrator levels (5, 10, 20 and 40ng/mL) and control levels (3.75 and 6.25ng/mL) were within specifications for Day 0, 3, 7, 10 and 13. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- မှ.
စာ Calibrator and Control Value Assignment - calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are out of the acceptable range, then the calibrator or control is adjusted and retested. Values are assigned to the calibrator and controls once the Mass spectrometry results are within the acceptable ranges.
H. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Buprenorphine Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.
11
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avente Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
July 1, 2014
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DR. POMONA CA 91767
Re: K141406
Trade/Device Name: Immunalysis Buprenorphine Urine Enzyme Immunoassay Immunalysis Buprenorphine Urine Controls Immunalysis Buprenorphine Urine Calibrators
Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG. DLJ. LAS Dated: May 23, 2014 Received: May 28, 2014
Dear Mr. Joseph Ginete:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,
If your device is classified (see above) into cither class II (Snecial Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
12
Page 2-Mr. Ginete
electronic product radiation control provisions (Scctions 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809). please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.lda.gov/MedicalDevices/Safety/ReportalProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
13
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K141406
Device Name
Immunalysis Burrenorphine Urine Enzyme Immunalysis Buprenorphine Urine Controls and Calibrators
Indications for Use (Describe)
Immunalysis Buprenorphine Urine Enzyme Immunoassay:
The Inmunalysis Buprenorphine Urine Enzyne Inmunoassay is a homogeneous corzyme immunoassay with a cutoff of Sng/mL. The assay is intended for use in laboratories for the quantitative and semi-quantitative analysis of Buprenorphine with automated clinical chemistry analyzers. This assay is calibrated against Burrenorphine. This in-vitro diagnostic device is for preseription use only.
The semi-quanitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the speciment for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Buprenorphine Urine Enryne Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liguid Chromatography / Mass Spectrospopy (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be any drug of abuse test result, particularly when preliminary positive results are used.
Immunalysis Buprenorphine Urine Controls:
The Immunalysis Buprenomhine Urine Control naterials in the Inimunalysis Buprenorphine Urine Enzyne Immunoassay.
Immunalysis Buprenorphine Urine Calibrators:
The Innunalysis Buprenomhine Urine Calibrators are used as calibrators in the Immunalysis Bunrenomhine Urine Enzyme Immunoassy for the qualitative and semination of Burgnomhine in urine on automated clinical chemistry analyzers.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)