What is the FDA product code for BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)?

DIS. It is classified under 21 CFR 862.3150 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)?

Emit® II Plus Barbiturate Assay (K010934); Multi-Drugs Urine Calibrators and Controls (K935101).

Who can help prepare an FDA 510(k) submission like BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)

Q: Who is the manufacturer of BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)?

Lin-Zhi International, Inc. filed the 510(k) submission for BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT) (K032764).

K032764 · Lin-Zhi International, Inc. · DIS · Nov 3, 2003 · Clinical Toxicology

Device Facts

Record ID	K032764
Device Name	BARBITURATE ENZYME IMMUNOASSAY, CA. # 0140 (500 TESTS KIT); CAT# 0141 (5000 TESTS KIT)
Applicant	Lin-Zhi International, Inc.
Product Code	DIS · Clinical Toxicology
Decision Date	Nov 3, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3150
Device Class	Class 2

Intended Use

The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy. The Barbiturate Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used.

Device Story

Device is a liquid, ready-to-use homogeneous enzyme immunoassay for barbiturate detection in human urine. Principle: competition between barbiturate-labeled G6PDH enzyme and free drug in urine for fixed antibody binding sites. In absence of drug, antibody binds labeled enzyme, inhibiting activity; drug concentration is proportional to enzyme activity. Activity measured spectrophotometrically at 340 nm via conversion of NAD to NADH. Used in professional clinical settings with automated chemistry analyzers. Provides preliminary results; requires GC/MS confirmation. Benefits include rapid screening for barbiturate use or overdose and therapeutic monitoring.

Clinical Evidence

Bench testing only. Performance evaluated via precision (within-run and run-to-run), sensitivity, accuracy, and analytical recovery. Accuracy compared to predicate (n=105) showed 91.1% agreement for positive samples and 100% for negative samples. Semi-quantitative accuracy demonstrated within ±15% of nominal concentration between 40 ng/mL and 800 ng/mL.

Technological Characteristics

Liquid, ready-to-use homogeneous enzyme immunoassay. Sensing principle: spectrophotometric measurement of G6PDH enzyme activity at 340 nm. Calibrators and controls are human urine-based. Designed for use on automated clinical chemistry analyzers. No specific software algorithm class or connectivity described; device is a reagent kit.

Indications for Use

Indicated for qualitative and semi-quantitative detection of barbiturates in human urine for professional use in clinical settings to aid in diagnosis/treatment of barbiturate use or overdose and monitoring therapy.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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).

Predicate Devices

Emit® II Plus Barbiturate Assay (K010934)
Multi-Drugs Urine Calibrators and Controls (K935101)

Related Devices

K161714 — Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators · Immunalysis Corporation · Oct 14, 2016
K012996 — BARBITURATES · Abbott Laboratories · Mar 20, 2002
K062165 — VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS · Ortho-Clinical Diagnostics · Jan 5, 2007
K033885 — BMBP ENZYME IMMUNOASSAY, CAT #0610, 0611 (500, 5000 TEST KIT) · Lin-Zhi International, Inc. · May 19, 2004
K993987 — SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL · Syva Co. · Jan 27, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ NOV - 3 2003 K632764 September 1, 2003 Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 9200 Corporate Blvd. Rockville, Maryland 20850 #### RE: Premarket Notification [510(k)] for Barbiturate Enzyme Immunoassa Attention: Document Control Clerk In accordance with the requirements of the Section 510(k) of the Federal Fod Cosmetic Act, Lin-Zhi International, Inc. hereby notifies you of its intention to introdu into interstate commerce for commercial distribution of the Barbiturate Enzyme Immunoassay for qualitative and semi-quantitative determination of barbiturates in human urine. This test kit is based on the principle of specific inhibition of enzyme activity of an enzyme-drug conjugate by the specific antibody to the drug, which is identical to the homogeneous enzyme immunoassay currently available Emit® II Plus Barbiturate Assay by Syva Company (Dade Behring Inc.) in the commercial distribution. The following information is being submitted in conformance to the requirements of 21 CFR 807.87: | 1. | Classification Name: Common/Usual Name: | Barbiturate Test System Homogeneous enzyme immunoassay for the determination of Barbiturates levels in urine. | |----|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Proprietary Name: | None | | | 2. Establishment Registration Number: | 3003610499 | | | 3. Classification: | The Barbiturate test system has been placed in Class II by the Bureau of Medical Devices. Classification Number: DIS (21 CFR 862.3150) Panel: 91 Toxicology | | | 4. Performance Standards: | No applicable standards have been established under Section 51- of the Act. | {1}------------------------------------------------ # 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted 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 provides sufficient detail to understand the basis for a determination of substantial equivalence. #### Submitter name, Address, and Contact Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849 | Contact: | Cheng-I Lin, Ph.D. President, R&D Director | |----------|-----------------------------------------------| |----------|-----------------------------------------------| #### Device Name and Classification | Classification Name: | Barbiturate test system, Class II, DIS (91 Toxicology), 21CFR 862.3150 | |----------------------|------------------------------------------------------------------------------------------| | Common Name: | Homogeneous enzyme immunoassay for the determination of Barbiturates levels in urine. | | Proprietary Name: | None | #### Legally Marketed Predicate Device(s) Lin-Zhi International, Inc.' Barbiturate Enzyme Immunoassay is substantially equivalent to Syva EMIT® II Plus Barbiturate Assay (By Syva Company-Dade Behring Inc.), cleared under premarket notification K010934. LZI's Barbiturate Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device components, and clinical performance. #### Device Description LZI's Barbiturate Enzyme Immunoassay is a ready-to-use, liquid reagent, homogeneous enzyme immunoassay. The assay uses specific antibody that can detect barbiturates in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. {2}------------------------------------------------ The assay is based on competition between barbiturate labeled with glucose-6-phosphate dehydrogenase (G6PDH) enzyme and free drug from the urine sample for a fixed amount of specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled G6PDH enzyme causing a decrease in enzyme activity. It is therefore the drug concentration is proportional to the enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically at 340 nm by measuring its ability to covert nicotinamide adenine dinucleotide (NAD) to NADH. #### Intended Use The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. #### Comparison to Predicate Device LZI's Barbiturate Enzyme Immunoassay is substantially equivalent to other products in commercially distribution intended for similar use. Most notably it is substantially equivalent to the currently, commercially marketed Emit® II Plus Barbiturate Assay (K010934) by Syva Company-Dade Behring Inc. The following table compares LZI's Barbiturate Enzyme Immunoassay with the predicate device, Emit® II Plus Barbiturate Assay by Syva Company-Dade Behring Inc. Similarities: - . Both assays are for qualitative and semi-quantitative determination of barbiturates in human urine. - Both have dual cutoff design (200 ng/mL or 300 ng/mL). . - Both assays use 5 points calibration for semi-quantitative determination. . - Both assays use secobarbital as calibrators and controls. ● - Both assays use the same method principle, and device components. . Difference: - . Syva's assay uses 150, 225, 250, 375 ng/mL for various control levels. LZI's assay uses 100, 200, 300, 400 ng/mL for various control levels. - Syva's assay uses 0, 100, 200, 300 and 800 ng/mL, LZI's assay uses 0, 100, . 200, 300 and 1000 ng/mL 5 points calibration for semi-quantitative assay. {3}------------------------------------------------ ### Performance Characteristics | Feature | SYVA's Barbiturate EIA | | | | LZI's Barbiturate EIA | | | | |-----------------------|------------------------------------------------------------|-------|-----|------|-----------------------------------------------|-------|-------|------| | Within Run Precision: | | | | | | | | | | Qualitative: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | | | Negative | 205.8 | 0.9 | 0.4 | Negative | 269.1 | 2.2 | 0.8 | | | 150 ng/mL | 242.1 | 1.0 | 0.4 | 100 ng/mL | 311.1 | 1.9 | 0.6 | | | 200 ng/mL | 258.4 | 1.2 | 0.5 | 200 ng/mL | 354.2 | 3.7 | 1.1 | | | 225 ng/mL | 266.9 | 1.1 | 0.4 | 300 ng/mL | 385.1 | 3.1 | 0.1 | | | 250 ng/mL | 276.4 | 1.2 | 0.4 | 400 ng/mL | 404.7 | 2.9 | 0.7 | | | 300 ng/mL | 295.8 | 1.4 | 0.5 | 1000 ng/mL | 445.3 | 2.7 | 0.6 | | | 375 ng/mL | 326.4 | 1.2 | 0.4 | | | | | | Semi-quantitative: | (ng/mL) | Mean | SD | %CV | (ng/mL) | Mean | SD | %CV | | | 150 ng/mL | 144.0 | 5.5 | 3.8 | 100 ng/mL | 99.0 | 4.7 | 4.8 | | | 200 ng/mL | 191.4 | 3.5 | 1.8 | 200 ng/mL | 194.7 | 7.4 | 3.8 | | | 225 ng/mL | 215.7 | 3.2 | 1.5 | 300 ng/mL | 294.3 | 8.3 | 2.8 | | | 250 ng/mL | 242.6 | 3.4 | 1.4 | 400 ng/ml | 386.5 | 13.7 | 3.6 | | | 300 ng/mL | 297.9 | 4.0 | 1.3 | Secobarb only | | | | | | 375 ng/mL | 390.1 | 3.8 | 1.0 | | | | | | Run-To-Run Precision: | | | | | | | | | | Qualitative: | (mA/min.) | Mean | SD | % CV | (mA/min.) | Mean | SD | % CV | | | Negative | 205.8 | 1.2 | 0.6 | Negative | 271.1 | 2.3 | 0.8 | | | 150 ng/mL | 242.1 | 1.4 | 0.6 | 100 ng/mL | 314.8 | 2.2 | 0.7 | | | 200 ng/mL | 258.4 | 1.5 | 0.6 | 200 ng/mL | 359.0 | 1.9 | 0.5 | | | 225 ng/mL | 266.9 | 1.7 | 0.6 | 300 ng/mL | 389.5 | 1.7 | 0.4 | | | 250 ng/mL | 276.4 | 1.7 | 0.6 | 400 ng/mL | 405.6 | 1.8 | 0.4 | | | 300 ng/mL | 295.8 | 1.9 | 0.6 | 1000 ng/mL | 447.4 | 1.6 | 0.4 | | | 375 ng/mL | 326.4 | 2.3 | 0.7 | | P 13 | | | | Semi-quantitative: | (ng/mL) | Mean | SD | %CV | (ng/mL) | Mean | SD | %CV | | | 150 ng/mL | 144.0 | 6.0 | 4.2 | 100 ng/mL | 102.7 | 3.2 | 3.1 | | | 200 ng/mL | 191.4 | 4.5 | 2.4 | 200 ng/mL | 191.6 | 9.3 | 4.9 | | | 225 ng/mL | 215.7 | 4.1 | 1.9 | 300 ng/mL | 290.3 | 14.0 | 4.8 | | | 250 ng/mL | 242.6 | 5.8 | 2.4 | 400 ng/ml | 385.3 | 12.7 | 3.3 | | | 300 ng/mL | 297.9 | 6.2 | 2.1 | | | P. 19 | | | | 375 ng/mL | 390.1 | 7.3 | 1.9 | | | | | | Sensitivity: | 20 ng/mL | | | | 25 ng/mL | | | | | Accuracy: | Vs. a commercial EIA | | | | Vs. Syva (n=105) | | | | | Positive Samples: | 95.6 % agreement | | | | 91.1 % agreement(100% vs. GC/MS /HPLC) | | | | | Negative Samples: | 99% agreement | | | | 100 % agreement | | | | | Analytical Recovery: | | | | | | | | | | | Qualitative: 100 % accuracy on positive vs. negative tests | | | | 100 % accuracy on positive vs. negative tests | | | | | Semi-quantitative | Quantitates within ±15% of the nominal | | | | Quantitates within ±15% of the nominal | | | | | | concentration between 40 ng/mL and 900 | | | | concentration between 40 ng/mL and 800 | | | | | | ng/mL. | | | | ng/mL. | | | | | | | | | | | | | | | Specificity: | See attached Syva's Barbiturate Assay | | | | Comparable to the predicate device. | | | | | | package insert | | | | | | | | the life រូប {4}------------------------------------------------ ### Conclusion LZI's Barbiturate Enzyme Immunoassay was evaluated for several performance characteristics including precision, sensitivity, accuracy, analytical recovery, and specificity. All the studies showed acceptable results when compared to the predicate device. We trust the information provided in this Premarket Notification [510(k)] submission will support a determination of substantial equivalence of the LZI's Barbiturate Enzyme Immunoassay to other Barbiturate test systems currently marketed in the United States. {5}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness This summary of 510(k) safety and effectiveness information is being submitted 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 provides sufficient detail to understand the basis for a determination of substantial equivalence. #### Submitter name, Address, and Contact Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Phone: (408) 732-3856 Fax: (408) 732-3849 | Contact: | Cheng-I Lin, Ph.D | |----------|-------------------| | | President | #### Device Name and Classification | (a) Classification Name: | Calibrators, Drug Specific; Class II, DLJ (91 Toxicology), 21 CFR 862.3200 | |--------------------------|---------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Secobarbital Calibrators | | Proprietary Name: | None | | (b) Classification Name: | Single (Specified) Analyte Controls (Assayed and Unassayed); Class I, LAS (91 Toxicology), 21 CFR 862.3280 | | Common/Usual Name: | Secobarbital Controls | | Proprietary Name: | None | ### Legally Marketed Predicate Device(s) Lin-Zhi International, Inc.'s Barbiturate Urine Drugs of Abuse Calibrators and Controls are substantially equivalent to the DRI's secobarbital calibrators and controls included in the Multi-Drugs Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications (K935101) for Drugs of Abuse Urine Calibrators and Controls. {6}------------------------------------------------ #### Device Description All of the Single Analyte Urine DAU Calibrators and Controls are human urine-based liquid, and ready to use. These Calibrators and Controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte. The Negative DAU calibrator is a processed, drug-free human urine matrix, which has also been used with all assays. The calibrators and controls are prepared by spiking known concentrations of drug analyte into the Negative DAU Calibrator matrix. The concentrations of drug analyte in the barbiturate calibrators and controls are summarized as follows: | | Barbiturate EIA | |------------------------------------|-----------------| | Reference Material | Secobarbital | | Calibrator #2/Control I | 100 ng/mL | | Calibrator #3/Cutoff A/Control II | 200 ng/mL | | Calibrator #4/Cutoff B/Control III | 300 ng/mL | | Calibrator #5 | 1000 ng/mL | | Control IV | 400 ng/mL | #### Intended Use The Barbiturate DAU Calibrators are intended for in vitro diagnostic use for the calibration of the barbiturate enzyme immunoassay to detect barbiturates in human urine. The Barbiturate DAU Controls are intended for in vitro diagnostic use for the validation of the barbiturate enzyme immunoassay to detect barbiturates in human urine. ### Comparison to Predicate Device LZI's Barbiturate DAU Calibrators and Controls are similar in intended use, matrix, and performance to the DRI's secobarbital calibrators and controls included in the Multi-Drug Urine Calibrators and Controls. Similarities: - Both are for the calibration of Barbiturate Enzyme Immunoassay to detect ● drug of abuse in human urine. - A total of 5 levels of calibrators including the negative calibrator for each analyte. ● - The nominal concentrations of the analyte in the calibrators and controls are determined and ● confirmed by GC/MS. - Both are urine-based liquids. ● - Storage condition is the same, at 2℃ to 8℃. ● - Performance characteristics on precision, accuracy and stability are similar. ● {7}------------------------------------------------ Differences: - The DRI's cutoff concentration is 200 ng/mL; LZI has 200 and 300 ng/mL cutoffs. . - For semi-quantitative assay, DRI uses 0, 100, 200, 500, and 1000 ng/mL as calibrators. . LZI uses 0, 100, 200, 300, and 1000 ng/mL as calibrators. - LZI uses 100 and 300 ng/mL as controls for 200 ng/mL cutoff, and uses 200 and 400 . ng/mL as controls for 300 ng/mL cutoff. DRI uses 150 and 300 ng/mL as controls for 200 ng/mL cutoff calibrator. ### Conclusion The information provided in the premarket notification demonstrates that the LZI's Barbiturate Drug of Abuse Calibrators and Controls are substantially equivalent to previously approved predicate devices, notably the DRI's Multi-Drug Urine Calibrators and Controls, and safe and effective for its intended use. {8}------------------------------------------------ | 5. Product Description: | Draft copies of (Attachment A) Product Insert, and (Attachment B) Product Labels, are submitted along with (Attachment C) Product Inserts from (i) Emit® II Plus Barbiturate Assay (by Dade Behring Inc.), (ii) Barbiturate Enzyme Immunoassay (DRI) | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 6. Substantial Equivalence: | The test kit utilizes specific antibody and antigen-enzyme conjugate binding principle identical to those used in the Enzyme Multiplied Immunoassay Technology (EMIT®). The reagent formulation is similar to those described in the Emit® II Plus Barbiturate Assay (by Dade Behring Inc.). Examination of the enclosed data will indicate that the current Barbiturate Enzyme Immunoassay is substantially equivalent to other commercially available test kits for determination of barbiturates in human urine. | We trust the information that we have provided is satisfactory and look forward to your review of this submission. Furthermore, a truthful and accurate statement, a 510 (k) summary, and an indications for use statement regarding to the current Barbiturate Enzyme Immunoassay are also submitted in accordance to the requirements of the 21 CFR 807.87(J), SMDA 1990, and 21 CFR807.92. Sincerely, Chang-Li Lin, Ph.D. Cheng-I Lin, Ph.D. President, R&D Director Lin-Zhi International, Inc. #### Confidentiality Lin-Zhi International requests the FDA not to disclose the nature or existence of the Premarket Notification until the substantial equivalence decision has been reached. {9}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three human profiles embedded within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. NOV - 3 2003 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Cheng-I Lin, Ph.D. President, R & D Director Lin-Zhi International, Inc. 687 North Pastoria Avenue Sunnyvale, CA 94085 Re: k032764 > Trade/Device Name: Barbiturate Enzyme Immunoassay Barbiturate Drug of Abuse Calibrators and Controls Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS; DLJ; LAS Dated: September 1, 2003 Received: September 5, 2003 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). {10}------------------------------------------------ Page 2 - 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Butman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {11}------------------------------------------------ ## Premarket Notification Supplement ## Indications for Use Statement KO32769 510(k) Number (if known): _ #### Device Name: Barbiturate Drug of Abuse Calibrators and Controls #### Indications for Use: The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine. The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) Albert Cati --- Division Sign-Off for Jean Cooper Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K032764 Page 2 {12}------------------------------------------------ ## Premarket Notification ### Indications for Use Statement # 510(k) Number (if known): ## Device Name: Barbiturate Enzyme Immunoassay #### Indications for Use: The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semiquantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy. The Barbiturate Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-ofabuse test result, particularly when preliminary positive results are used. Albert Cill'\n**Division Sign-Off** to. Jean Cooper Office of In Vitro Diagnostic Device Evaluation and Safety Concurrence of CDRH, Office of Prescription Use (Per 21 CFR 801.109) OR #### Over-The-Counter Use (Optional Format 1-2-96)