(195 days)
The Barbiturates assay is used for the qualitative analysis of barbiturates in human urine with a cutoff of 200 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of barbiturates use or overdose. The Barbiturates assay is calibrated with secobarbital and will detect a variety of Barbiturates. The Barbiturates assay 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) 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.
Barbiturates is an in vitro diagnostic assay for the qualitative analysis of barbiturates in human urine. The assay is a homogeneous enzyme immunoassay with a 200 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Barbiturates assay:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a predicate device and GC/MS, rather than explicitly stated as numerical targets. The overall goal is "acceptable correlation" and "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Emit® II Barbiturate assay on SYVA®-30R) for qualitative analysis. | Concordance with Predicate Device (Emit® II Barbiturate assay): 96% agreement. Six samples were negative by Emit II but positive by the Barbiturates assay; these were confirmed by GC/MS to contain phenobarbital between 661 and 1,048 ng/mL (well above the 200 ng/mL cutoff). This suggests the new assay might be more sensitive or detecting a broader range of barbiturates, aligning with "acceptable correlation." |
| Acceptable correlation with GC/MS (confirmatory method) | Concordance with GC/MS: 100% agreement. (This is stated after mentioning the 6 samples confirmed by GC/MS, implying that when GC/MS was used as the reference, the Barbiturates assay matched). |
| Acceptable precision | Precision Studies (Total %CV): |
| - Verifier I: 0.47% | |
| - Cutoff Calibrator: 0.53% | |
| - Verifier II: 0.55% | |
| -25% Control of Cutoff Calibrator: 0.61% | |
| +25% Control of Cutoff Calibrator: 0.55% | |
| Limit of Detection (Sensitivity) | 20 ng/mL |
| Device cutoff for qualitative analysis (200 ng/mL) | Barbiturates assay cutoff: 200 ng/mL (Matches the intended use and predicate device's cutoff for qualitative analysis, which is implied as similar to the new device's qualitative nature). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): The document doesn't explicitly state the total number of samples used for the comparative performance studies. It mentions that "Six samples were negative using the Emit II Barbiturate assay on the SYVA-30R Analyzer and positive using the Barbiturates assay," and then were confirmed by GC/MS. It also states "The clinical specimens tested ranged from 302 to 6,481 ng/mL." This suggests a set of clinical specimens was used, but the exact number isn't provided.
- Data Provenance: Not specified. It's unclear if the data is prospective or retrospective, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable/not mentioned. The ground truth for the comparison studies was established using a predicate device (Emit II Barbiturate assay) and Gas Chromatography/Mass Spectrometry (GC/MS), which is an analytical chemical method, not human expert interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The "adjudication" was primarily through comparison to a well-established predicate laboratory device and a gold standard analytical method (GC/MS). If there were discrepancies between the new assay and the predicate, GC/MS was used as the definitive adjudicator (as seen with the 6 samples mentioned).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- MRMC Study: No, an MRMC study was not done. This device is an in vitro diagnostic assay (laboratory test), not an AI-powered image analysis or diagnostic support tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the entire study focuses on the standalone performance of the Barbiturates assay (an IVD kit) as evaluated on the AEROSET® System. It assesses the assay's performance characteristics (concordance, precision, sensitivity) independently.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- Predicate Device Performance: Comparison to the Emit® II Barbiturate assay on the SYVA®-30R Analyzer served as a primary reference point for establishing "substantial equivalence."
- Gas Chromatography/Mass Spectrometry (GC/MS): This was used as the definitive "gold standard" confirmatory method, especially for resolving discrepancies between the new assay and the predicate (e.g., the 6 discrepant samples). GC/MS is an objective analytical method.
8. The Sample Size for the Training Set
- Sample Size (Training Set): Not specified. For IVD assays, "training sets" are usually not applicable in the same way they are for AI/ML. The assay is developed based on chemical/biological principles and calibrated, not "trained" on data to learn patterns. The calibration process implicitly uses specific samples (e.g., the 200 ng/mL cutoff calibrator), but a "training set" size for algorithm development isn't relevant here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth (Training Set): Not applicable in the context of an IVD assay's "training set." The assay's fundamental chemistry and cutoff (200 ng/mL, calibrated with secobarbital) are established through analytical chemistry and toxicology principles, not a data-driven "ground truth" as in machine learning model training.
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MAR 2 0 2002
510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive MS 1-8 Irving, Texas 75038
Contact Person Linda Morris Senior Regulatory Affairs Specialist Regulatory Affairs (972) 518-6711 Fax (972) 753-3367
Date of Preparation of this Summary: November 21, 2001 Barbiturates Device Trade or Proprietary Name: Device Common/Usual Name or Classification Name: Barbiturates Classification Number/Class: KLT/Class II
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.
The assigned 510(k) number is: K012996.
Test Description:
Barbiturates is an in vitro diagnostic assay for the qualitative analysis of barbiturates in human urine. The assay is a homogeneous enzyme immunoassay with a 200 ng/mL cutoff. The assay is based on competition between drug in the specimen and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites. Enzyme activity decreases upon binding to the antibody, so the drug concentration in the specimen can be measured in terms of enzyme activity. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically.
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Substantial Equivalence:
The Barbiturates assay is substantially equivalent to the Emit® II Barbiturate assay (K902580) on the SYVA®-30R Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro immunoassays. .
- Both assays can be used for the qualitative analysis of barbiturates. .
- Both assays yield similar results. .
- Both assays are based on the competition between drug in the specimen and drug labeled with the . enzyme glucose-6-phosphate dehydrogenase (G6PDH) for antibody binding sites.
Differences:
- There is a difference between the assay ranges. .
- Barbiturates is a qualitative assay. Emit II is a qualitative and semiquantitative assay. .
Intended Use:
The Barbiturates assay is used for the qualitative analysis of barbiturates in human urine with a cutoff of 200 ng/inL. For use in clinical laboratories,
The Barbiturates assay is calibrated with secobarbital and will detcct a variety of Barbiturates.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET® System. The Barbiturates assay method comparison yielded acceptable correlation with the Emit II Barbiturate assay on the SYVA-30R Analyzer. The concordance table for the Barbiturates assay shows 96% agreement. Six samples were negative using the Emit II Barbiturate assay on the SYVA-30R Analyzer and positive using the Barbiturates assay. These samples were shown to contain 829, 898, 661, 998, 1,048 and 969 ng/ml. of phenobarbital as determined by GC/MS. The Barbiturates assay method comparison yicl(led acceptable correlation with GC/MS. The concordance table for the Barbiturates assay shows 100%
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agreement with GC/MS. The clinical specimens tested ranged from 302 to 6,481 ng/mL. Precision studies were conducted using the Barbiturates assay. A within-run and total precision study was performed using five levels of control material. The total %CV for Verifier I is 0.47%. The total %CV for the Cutoff Calibrator is 0.53%. The total %CV for Verifier II is 0.55%. The total %CV for the - 25% Control of Cutoff Calibrator and the + 25% Control of Cutoff Calibrator samples are 0.61% and 0.55%, respectively. The Barbiturates assay cutoff is 200 ng/mL. The limit of detection (sensitivity) of the Barbiturates assay is 20 ng/mL. These data demonstrate that the performance of the Barbiturates assay is substantially equivalent to the performance of the Emit II Barbiturate assay on the SYVA 30R Analyzer.
Conclusion:
The Barbiturates assay is substantially equivalent to the Emit II Barbiturate assay on the SYVA-30R Analyzer as demonstrated by results obtained in the studies.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAR 2 0 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda Morris Senior Regulatory Affairs Specialist Abbott Laboratories 1921 Hurd Dr. Irving. Texas 75038
K012996 Re:
Trade/Device Name: Barbiturates Regulation Number: 21 CFR 862.3150 Regulation Name: Batbiturate test system Regulatory Class: Class II Product Code: DIS Dated: November 26, 2001 Received: November 28, 2001
Dear Ms. Morris:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfal in the encreated 976, the enactment date of the Medical Device Amendments, or to commerce pror to Hay 20, 277, 2011 - 11:21
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). and Cosmetion (110-) that to nevice, subject to the general controls provisions of the Act. The rou may, mereleve, mains of the Act include requirements for annual registration, listing of general oonly of of returing 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 If your device is exassinod (tional 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 r lease oc devisou that I Dr bration that your device complies with other requirements of the Act that I Dr Has Intactions and regulations administered by other Federal agencies. You must or any I vatural the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It Fat 807), accesses (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - 1
This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and in you to or substantial equivalence of your device to a legally marketed notification. The I Dr I milling of section 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 Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m Trius claguestions on the promotion and advertising of your device, (201) 594-4560. Raditional J), collance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountactor on your respondiationsumer Assistance at its toll-free number (800) 638-2041 or Manufactoreror meetimet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K012996
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Barbiturates assay is used for the qualitative analysis of barbiturates in human urine with a cutoff of 200 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatment of barbiturates use or overdose.
The Barbiturates assay is calibrated with secobarbital and will detect a variety of Barbiturates.
The Barbiturates assay 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) 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use_ ✓(Per 21 CFR 801.109) | OROver-The-Counter Use_ (Optional Format 1-2-96) |
R.A.
(Division Sign-Off
Division:
510(k) Number K012996
§ 862.3150 Barbiturate test system.
(a)
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.(b)
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).