Amendment - N62645-20-R-0005 0001.docx

N6264520R0005

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS AND ANSWERS

QUESTION #1

Reference Performance Work Statement (PWS) section 2.1: The reagents supplied shall be compatible with the calibration requirements and characteristics of the Beckman Coulter AU5800 Series Clinical Chemistry Analyzers. Verification of each calibration, at 1 ng/mL, shall be accomplished with a drug-free control and open controls at target concentrations of 50-75% and 150-200% of the calibrator/cutoff. An acceptable verification will demonstrate analytical readings as follows: drug-free control < 50-75% control < cutoff (calibrator) < 150-200% control. The batch may also contain blind negative and positive controls distributed throughout the batch.

Offeror’s comment: The controls in our FDA cleared fentanyl assay are fortified at ……..……….. These are the levels that we have 95% reliability and 95% confidence of no overlap with the 1 ng/mL cutoff concentration.

Offeror’s question: Is the DoD open to changing the specification for verification of each calibration at 1 ng/mL to read “shall be accomplished with a drug free control and open controls at target concentration of 50% and 150-200% of the calibrator/cutoff?”

Government’s response: No. The Government continuously evaluates its own standards and requirements and will make changes as necessary.

QUESTION #2

Reference PWS section 3.5: The reagent shall produce non-overlapping ranges for quality control (QC) samples analyzed at 0%, 50%, 100%, 150%, and 200% of the calibrator/cutoff concentration.

If the DoD maintains the QS controls at these concentrations (especially the 50% of the calibrator cutoff concentration) as specified in the above clause then our concerns with the range in clause 2.1 is mitigated.

Reference PWS section 4: QUALITY ASSURANCE PROGRAM OF THE MANUFACTURING PROCESS SHALL POSSESS CURRENT ISO-9000 SERIES CERTIFICATION OR INCLUDE DOCUMENTATION OF THE FOLLOWING ELEMENTS:

Offeror’s comment: [Offeror] is certified to the ISO 13485 standard. This comprehensive management system specifically for the manufacture of medical devices. It places a focus on regulatory compliance and covers all the requirements listed in subclauses of Section 4.1 through 4.4 of the Statement of Work.

Offeror’s question: Will the DoD accept the ISO 13485 management system certification?

Government’s response: Yes. ISO 13485 is the ISO 9000 series certification specific to the manufacture of medical devices.

QUESTION #3

Reference PWS section PERFORMANCE TESTING: 1.3.3.3. The coefficients of variation (CVs) of the 20 replicate values at 75%, 100%, 125%, 150%, and 200% of the CAL should be less than 10% within each run and less than 15% within the three timed runs.

Offeror’s comment: Because of its potency, fentanyl concentrations detected in users are far lower than those present in users of other opioids such as oxycodone and morphine, because of this the cutoff concentration for Fentanyl assay is extremely low at 1ng/mL. For example, this is 10-fold lower than the 6-Acetyl Morphine assay which has a cutoff of 10 ng/mL.

Offeror’s question: Given the low concentration would the DoD consider changing the C.V. specification for the 20 replicates of 75%,100%,125%,150% and 200% of the CAL be raised to less than 15% within each run and less than 20% within the three timed runs?

Government’s response: No. The Government continuously evaluates its own standards and requirements and will make changes as necessary.

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