42 CFR 493.1253 - Standard: Establishment and verification of performance specifications.

§ 493.1253 Standard: Establishment and verification of performance specifications.

(a)Applicability. Laboratories are not required to verify or establish performance specifications for any test system used by the laboratory before April 24, 2003.


(1)Verification of performance specifications. Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results:

(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics:

(A) Accuracy.

(B) Precision.

(C) Reportable range of test results for the test system.

(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population.

(2)Establishment of performance specifications. Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable:

(i) Accuracy.

(ii) Precision.

(iii) Analytical sensitivity.

(iv) Analytical specificity to include interfering substances.

(v) Reportable range of test results for the test system.

(vi) Reference intervals (normal values).

(vii) Any other performance characteristic required for test performance.

(3)Determination of calibration and control procedures. The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section.

(c)Documentation. The laboratory must document all activities specified in this section.

[ 68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]

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United States Code

Title 42 published on 11-Jul-2018 05:04

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 493 after this date.

  • 2018-01-09; vol. 83 # 6 - Tuesday, January 9, 2018
    1. 83 FR 1004 - Request for Information: Revisions to Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations and Fee Regulations Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Request for information.
      To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on March 12, 2018.
      42 CFR Part 493