← Product Code [DIF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF) · K960244 # DOCUMENT TDM ULTRA ASSAYED CONTROL (K960244) _Casco Standards · DIF · Mar 22, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K960244 ## Device Facts - **Applicant:** Casco Standards - **Product Code:** [DIF](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF.md) - **Decision Date:** Mar 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3280 - **Device Class:** Class 1 - **Review Panel:** Clinical Toxicology ## Indications for Use This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies. ## Device Story DOCUMENT™ TDM ULTRA Assayed Control is a liquid human serum matrix containing 25 analytes; used as a quality control material for automated and semi-automated immunochemistry and clinical chemistry systems. The device provides a stable, ready-to-use control to assess analytical performance, monitor accuracy/precision, and assist in troubleshooting system, reagent, or calibration issues. It is used by laboratory personnel in clinical settings to verify that diagnostic systems are functioning within expected parameters for the listed therapeutic drugs, thyroid hormones, and ethanol. ## Clinical Evidence Bench testing only. Equivalence established by comparing inter-assay precision of the 25 analytes in the DOCUMENT™ TDM ULTRA Assayed Control against the performance of the three predicate devices. Results indicate the subject device behaves in a similar manner to the predicates and is suitable for use as a control for the listed analytes. ## Technological Characteristics Liquid human serum matrix; contains 25 analytes; provided in three levels (I, II, III); packaged in plastic containers with dropper tips; ready-to-use (no dilution required); 30-day open-vial stability. ## Regulatory Identification A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials. ## Predicate Devices - Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3 - Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels - Abbott REA Ethanol Serum Control, Levels L, M, and H ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K96C344 MAR 22 13:51 Exhibit 15. 510(k) Summary FEDERAL FOOD, DRUG AND COSMETIC ACT 510(k) SUMMARY DOCUMENT™ TDM ULTRA Assayed Control, Levels I, II, III 1. Submitted by: CASCO Standards P.O. Box 970 Yarmouth, ME 04096 Attention: Christine V. Beach Manager, Regulatory Affairs (207) 878-7550 (207) 878-7578 FAX January 5, 1996 2. Product Name: Proprietary Name: DOCUMENT™ TDM ULTRA Assayed Control Classification Name: Control, multiple analyte, assayed. Page • 80 • {1} Page • 81 • # 3. Predicate Device: Product: Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3 Catalog: Level 1 (B5700-6), Level 2 (B5700-7), Level 3 (B5700-8) Manufacturer: BaxterDiagnostics, Inc., Deerfield, IL 60015-4633 Analytes: ACET, AMI, CARB, DIG, DISO, ETHO, GENT, LIDO, NAPA, PHENO, PHENY, PRIM, PROC, QUIN, SAL, THEO, hTSH, T4, TOB, T3, TU, VAL Product: Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels Catalog: Low (2841-31), High (2842-31) Manufacturer: Instrumentation Laboratory Company, Lexington, MA 02173-3190 Analytes: METH, VANCO Product: Abbott REA Ethanol Serum Control, Levels L, M, and H Catalog: 9545-11 Manufacturer: Abbott Laboratories, Abbott Park, IL 60064 Analytes: ETOH # 4. Product Description: **DOCUMENT® TDM ULTRA Assayed Controls** consist of three levels of a human serum matrix containing 25 commonly monitored analytes. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT), lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO). # 5. Intended Use: This product is intended for *in vitro* diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies. {2} 6. Comparison to the Predicate Device: | Characteristic | DOCUMENT® TDM ULTRA Assayed Control | Dade Immunoassay Comprehensive Tri-Level Control | Instrumentation Laboratories TheraChem TDC Therapeutic Drug Control | Abbott REA Ethanol Serum Control | | --- | --- | --- | --- | --- | | Intended Use | To assess the analytical performance of analytical systems in the quantitative measurement of therapeutic drugs, thyroid function, and ethanol | Assist in monitoring accuracy and precision in clinical assays | Control material for procedures used to quantitate levels of therapeutic drugs and thyroid hormones in serum specimens | Controls for the validation of calibration of the REA Ethanol assay on the TDxFLx, TDx, or ADx | | Number of Levels | Three (3): Level I, Level II Level III | Three (3): Level 1, Level 2, Level 3 | Two (2): Low, High | Three (3): L, M, H | | Type | Assayed | Assayed | Assayed | Assayed | | Analytes | 25 | 64 | 30 | 1 | | Volume | 5 mL | 5 mL | 5 mL | 4 mL | | Matrix | Human serum, Liquid | Human source, Lyophilized | Bovine serum, Lyophilized | Human blood components, Liquid | | Dilution | None required | None required | None required | None required | | Unopened Stability | Until Expiration Date | Until Expiration Date | Until Expiration Date | Until Expiration Date | | Open Stability | 30 Days | Varies with analyte following reconstitution | Up to four weeks after reconstitution | Until expiration date | | Container | Plastic, Dropper Tip | Glass | Glass | Plastic | Page • 82 • {3} Page • 83 • # 7. Test Results: The equivalence for this product was carried out by comparing the inter-assay precision of the listed analytes of the **DOCUMENT™** TDM ULTRA Assayed Control to that of Dade Immunoassay Controls Comprehensive Tri-Level, Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls and Abbott REA Ethanol Serum Control. The results show that the **DOCUMENT™** TDM ULTRA Assayed Control behaves in a similar manner compared to the predicate devices and is suitable for use as a control for the listed analytes. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K960244](https://fda.innolitics.com/submissions/CH/subpart-d%E2%80%94clinical-toxicology-test-systems/DIF/K960244) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com